Overview Software Engineer-II will be involved in the development of software technologies for medical devices. The right candidate will be proactive, with great communication skills, demonstrate attention to details, have a passion for technology, and an excitement to produce great products. Software Engineer-II shall be responsible for the development of software projects associated with Spacelab’s product development activities. Personal development skills in requirements definition, design, implementation, and testing/debugging are essential. Participation in planning, requirements analysis, and coordination with leads, must be comfortable in all phases of the software development lifecycle (SDLC). Responsibilities RESPONSIBILITIES: Adhere to Software development process and medical device standards (IEC 62304). Complete assigned tasks on time and in accordance with the appropriate process, including all QMS and regulatory requirements. Assist in defining and reviewing requirements and use cases. Find creative solutions from broadly defined problems or directives. Requirement’s analysis and generation. Configure, build, and test the application or technical architecture components. Fix any defects and performance problems discovered during testing. Cultivate and maintain knowledge of system integration. Ensure that all project tasks and deliverables conform to the appropriate processes and procedures. Ensure all software components unit/integration tested. Demonstrate ownership and responsibility for assigned tasks. Proactively communicate inside and outside the development team. Uphold Spacelabs values of Customer Obsession, Ownership Mindset and Superior Results. Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct. It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem. Duties may be modified or assigned at any time to meet the needs of the business. Good written and oral communication skills. Good documentation skills and software process discipline. Experience: Significant Programming experience in C, C++ 11/14/17 Experience in Qt, QML. Hands-on object-oriented software design and development experience with a solid grasp of C++, data structures, algorithms, and design/UI patterns. Handson experience in multithreading and Boost C++ libraries. Handson experience in Linux Experience in Azure DevOps Exceptional Debugging, Analytical and Problem-solving skills Collaborate with design engineers and clinical engineering team on translating product requirements into software design and create software specification documents. Experience is preferred in the medical device industry and good knowledge of FDA regulations. Scripting experience in Python and familiarity in working with Linux environment is desired. Working experience quickly to ramp-up on complex software components and ability to learn and deliver new languages/frameworks as required. Demonstrated experience in Design/Implementation for end-to-end medical device product development. Qualifications Total Years of Experience: 6 + years B.E/B.Tech (M.E/M.Tech preferred) in the fields of ECE, CS or MCA degree. Certified Qt and QML Developer is a plus and C++ certification. OSI Systems, Inc. has three operating divisions: (a) Security, providing security and inspection systems, turnkey security screening solutions and related services; (b) Healthcare, providing patient monitoring, diagnostic cardiology and anesthesia systems; and (c) Optoelectronics and Manufacturing, providing specialized electronic components and electronic manufacturing services for original equipment manufacturers with applications in the defense, aerospace, medical and industrial markets, among others. Show more Show less
Overview The Software Test Engineer II is responsible for testing software products through the use of systematic tests to develop, apply, and maintain quality standards. Part of the software QA team, whose job is to ensure our products meet specifications, customer expectations, and all QMS/regulatory requirements. It is an important part of delivering our mission to provide quality products that meet the needs of the caregiver and the patient. Responsibilities Evaluate, develop and execute test plans and strategies. Analyze, develop, maintain, and upgrade test scripts and automated test framework as per requirments. Write, implement, and report status for system test cases for testing, to assist in debugging and modification of software. Document test execution. Analyze automated test scripts to ensure functionality and recommend corrective action. Design and create software test harnesses or automated test scripts. Maintain good documentation. Provide regular progress reports. File issues/bugs with accurate details. Ensure all QMS and regulatory requirements are met. Participate in the review of requirements and designs. Evaluate software designs to understand best test implementations. Complete assigned tasks on-time and in accordance with the appropriate process. Continue to advance skills professionally and technically. Uphold the Company’s core values of Integrity, Innovation, Accountability, and Teamwork. Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct. It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem. Duties may be modified or assigned at any time to meet the needs of the business. Qualifications Bachelor’s/Master's degree in computer science, Engineering or related field with 6+ years of experience. Experience in Medical device testing and device simulators, firmware testing preferrably 2+ years Knowledge of software testing and testing life cycle. Must be able to use PC and Microsoft Office tools. Experience and strong knowledge of Microsoft OS, Ubuntu OS, Linux. Awareness of Test Management tools like SpiraTest, MTM, Bug tracking tools like TFS. Strong experience with Azure Dev Ops. Strong experience in Squish with Python scripting language.In the absence of Squish experience. Experience with Docker Swarm set up and environment. Experience in Software Configuration Management, especially experience with source control tools, Git. Experience of working in Agile Scrum methodology. Knowledge of commonly used concepts, practices, and procedures for software & system testing for medical devices. Ability to understand configuration and set-up of equipment for testing and development for medical devices. Good documentation skills and discipline. Experience in Medical/Aerospace/Automotive Domain. Experience with Regressions, End to End testing, dry runs and Adhoc testing. Medical device development knowledge, including V&V; activities, V&V protocol development, creating verification plans and verification Summary reports. Expertise in verification of Embedded software. Able to develop and execute test cases which require hardware interfaces. Ability to work on cross-functional project teams comprised of software verification and development engineers, system engineers, and quality engineers. Familiarity with the medical standards like IEC 62304 and ISO 13485. Experience working positively and productively in a team environment. Highly collaborative. Proactive communicator, with good written and oral communication skills. Ability to accomplish assigned tasks with minimal supervision. Able to draw on experience and judgment to make effective decisions. OSI Systems, Inc. has three operating divisions: (a) Security, providing security and inspection systems, turnkey security screening solutions and related services; (b) Healthcare, providing patient monitoring, diagnostic cardiology and anesthesia systems; and (c) Optoelectronics and Manufacturing, providing specialized electronic components and electronic manufacturing services for original equipment manufacturers with applications in the defense, aerospace, medical and industrial markets, among others.
Overview The Software Test Engineer II is responsible for testing software products through the use of systematic tests to develop, apply, and maintain quality standards. Part of the software QA team, whose job is to ensure our products meet specifications, customer expectations, and all QMS/regulatory requirements. It is an important part of delivering our mission to provide quality products that meet the needs of the caregiver and the patient. Responsibilities Evaluate, develop and execute test plans and strategies. Analyze, develop, maintain, and upgrade test scripts and automated test framework as per requirments. Write, implement, and report status for system test cases for testing, to assist in debugging and modification of software. Document test execution. Analyze automated test scripts to ensure functionality and recommend corrective action. Design and create software test harnesses or automated test scripts. Maintain good documentation. Provide regular progress reports. File issues/bugs with accurate details. Ensure all QMS and regulatory requirements are met. Participate in the review of requirements and designs. Evaluate software designs to understand best test implementations. Complete assigned tasks on-time and in accordance with the appropriate process. Continue to advance skills professionally and technically. Uphold the Company’s core values of Integrity, Innovation, Accountability, and Teamwork. Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct. It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem. Duties may be modified or assigned at any time to meet the needs of the business. Qualifications Bachelor’s/Master's degree in computer science, Engineering or related field with 6+ years of experience. Experience in Medical device testing and device simulators, firmware testing preferrably 2+ years Knowledge of software testing and testing life cycle. Must be able to use PC and Microsoft Office tools. Experience and strong knowledge of Microsoft OS, Ubuntu OS, Linux. Awareness of Test Management tools like SpiraTest, MTM, Bug tracking tools like TFS. Strong experience with Azure Dev Ops. Strong experience in Squish with Python scripting language.In the absence of Squish experience. Experience with Docker Swarm set up and environment. Experience in Software Configuration Management, especially experience with source control tools, Git. Experience of working in Agile Scrum methodology. Knowledge of commonly used concepts, practices, and procedures for software & system testing for medical devices. Ability to understand configuration and set-up of equipment for testing and development for medical devices. Good documentation skills and discipline. Experience in Medical/Aerospace/Automotive Domain. Experience with Regressions, End to End testing, dry runs and Adhoc testing. Medical device development knowledge, including V&V; activities, V&V protocol development, creating verification plans and verification Summary reports. Expertise in verification of Embedded software. Able to develop and execute test cases which require hardware interfaces. Ability to work on cross-functional project teams comprised of software verification and development engineers, system engineers, and quality engineers. Familiarity with the medical standards like IEC 62304 and ISO 13485. Experience working positively and productively in a team environment. Highly collaborative. Proactive communicator, with good written and oral communication skills. Ability to accomplish assigned tasks with minimal supervision. Able to draw on experience and judgment to make effective decisions. OSI Systems, Inc. has three operating divisions: (a) Security, providing security and inspection systems, turnkey security screening solutions and related services; (b) Healthcare, providing patient monitoring, diagnostic cardiology and anesthesia systems; and (c) Optoelectronics and Manufacturing, providing specialized electronic components and electronic manufacturing services for original equipment manufacturers with applications in the defense, aerospace, medical and industrial markets, among others.
Overview Software Engineer-I will be involved in the development of software technologies for medical devices. The right candidate will be proactive, with great communication skills, demonstrate attention to details, have a passion for technology, and an excitement to produce great products. Software Engineer-I shall be responsible for the development of software projects associated with Spacelab’s product development activities. Personal development skills in requirements definition, design, implementation, and testing/debugging are essential. Participation in planning, requirements analysis, and coordination with leads, must be comfortable in all phases of the software development life cycle (SDLC),Willing to contribute to Integration testing and system test on need basis. Responsibilities Adhere to Software development process and medical device standards (IEC 62304). Complete assigned tasks on time and in accordance with the appropriate process, including all QMS and regulatory requirements. Assist in defining and reviewing requirements and use cases. Find creative solutions from broadly defined problems or directives. Requirement’s analysis and generation. Configure, build, and test the application or technical architecture components. Fix any defects and performance problems discovered during testing. Cultivate and maintain knowledge of system integration and involve in integration test activities to find the integration issues and fix them. Good hands on with Integration and system tests and willing to participate. Ensure that all project tasks and deliverables conform to the appropriate processes and procedures. Ensure all software components unit/integration tested. Demonstrate ownership and responsibility for assigned tasks. Proactively communicate inside and outside the development team. Uphold Spacelabs values of Customer Obsession, Ownership Mindset and Superior Results. Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct. It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem. Duties may be modified or assigned at any time to meet the needs of the business. Good written and oral communication skills. Good documentation skills and software process discipline. Qualifications Total Years of Experience: 4 + years. Significant Programming experience in C, C++ 11/14/17 Experience in Qt, QML. Hands-on object-oriented software design and development experience with a solid grasp of C++, data structures, algorithms, and design/UI patterns. Hands on experience in multithreading and Boost C++ libraries. Hands on experience in Linux. Experience in Azure DevOps and bug life cycle. Exceptional Debugging, Analytical and Problem-solving skills Collaborate with design engineers and clinical engineering team on translating product requirements into software design and create software specification documents. Experience is preferred in the medical device industry and good knowledge of FDA regulations. Scripting experience in Python and familiarity in working with Linux environment is desired. Working experience quickly to ramp-up on complex software components and ability to learn and deliver new languages/frameworks as required. Demonstrated experience in Design/Implementation for end-to-end medical device product development. B.E/B.Tech (M.E/M.Tech preferred) in the fields of ECE, CS or MCA degree. Certified Qt and QML Developer is a plus and C++ certification.
Overview The Director of Research and Development is a highly motivated, technically savvy team builder who enjoys a fast-paced work environment, the freedom to establish a strategic vision and then execute on it and can obtain tangible results in a short period of time. A proven track record of success in medical device development is a must, with the expectation that the same success be obtained in this position. Responsibilities include managing the planning and execution of electromechanical product development, engineering staff development, and overall responsibility for ensuring that electromechanical development efforts are successful within a larger product development program. This role includes significant responsibility for managing and leading a remote site in India. Responsibilities RESPONSIBILITIES: Engineering Activities: Plans and directs engineering activities with overall responsibility for the design and development of all electromechanical projects. Policy Compliance: Ensures all engineering projects, initiatives, and processes are in conformance with the organization's established policies and objectives. Product Development: Integral part of a product development organization that delivers market-leading medical products on time and under budget. Team Leadership: Builds, leads, manages, and coaches an engineering team of 60+. Remote Site Management: Manages and leads multi-site development activities, including a staff in India. Responsible for ensuring the remote site meets all KPIs on time and within budget. Ensures the site is integrated and well-represented. Innovation: Continuously seeks innovative ways to improve development productivity through the introduction of new technologies, systems, methods, and controls. Development Tools: Selects, implements, and trains engineering development tools. Stakeholder Collaboration: Works closely with other key stakeholders to define new products and ensure products meet or exceed customer requirements. Process Improvement: Establishes product development processes and metrics that effectively measure and improve team performance. Technology Trends: Monitors technological trends such as emerging standards and new technology opportunities. Resource Management: Engages requisite staff resources on a full-time or contract basis according to work level demands and budgetary constraints. Budgeting: Helps develop capital, operating, staffing, and project budgets; establishes annual department operating objectives and plans; and makes staffing and compensation decisions. Project Monitoring: Monitors project status, taking or approving corrective action as required in terms of schedules, budgets, priorities, staffing, and work quality. Competency Development: Ensures that engineering professionals are fully competent for their roles, effectively organized to deliver service to users, and receive appropriate training and mentoring. Core Values: Uphold the Company’s core values of Integrity, Innovation, Accountability, and Teamwork. Ethics and Conduct: Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct. Ensure that direct report(s) are trained and evaluated on their knowledge and adherence to the Company’s values, Code of Ethics and Conduct, and applicable compliance policies. Quality Reporting: It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem. Flexibility: Duties may be modified or assigned at any time to meet the needs of the business. Leadership: Demonstrate open-mindedness and innovative thinking, empowering team members and fostering a collaborative culture. Represent a modern leadership style that is adept at guiding the new generation of engineers and leaders. Culture Building: Cultivate a transparent work environment that empowers and encourages personal and professional development with empathy. Budget Management: Develops research and development budget and manages expenses in line with organizational objectives; approves R&D expenditures including capital and manpower expenses. Team Creation: Creates and nurtures effective teams, effectively managing uncertainty and transitions, building and maintaining varied interpersonal connections, and engaging with senior management. Infrastructure Collaboration: Works with the infrastructure team to ensure the environment is available to support software and hardware development needs. Employee Engagement: Fosters employee engagement by actively promoting organizational diversity, nurturing a positive culture, and encouraging team-building activities. Functional Operations: Leads functional and departmental operations, overseeing talent planning, performance management, salary administration, and employee relations within the organization. Team Development: Coaches, mentors, and develops teams to enhance their effectiveness and boost employee engagement by fostering a collaborative and learning environment. Technology Analysis: Analyzes the external technology landscape to identify opportunities for the R&D team to collaborate with external partners or acquire technology that meets organizational needs. Project Lifecycle Management: Oversees the lifecycle of sustaining projects, ensuring they meet objectives and deliverables. Adaptability: Demonstrates adaptability and resilience to thrive in a dynamic and competitive environment. Flexible and agile in adjusting plans and priorities according to the changing needs and expectations of the market, customers, and organization. Continuous Learning: Constantly seeks to update and expand the knowledge and skills for self and team to stay relevant and competitive in the field. Problem Solving: Exhibits problem-solving skills and strategic planning to shape the organization’s direction. STRATEGIC LEADERSHIP: R&D Strategy: Develops and executes the overall R&D strategy, aligning it with the company's goals and identifying future research directions. R&D Management: Oversees all stages of the R&D lifecycle, ensuring projects are on time, within budget, and meet regulatory standards. Team Building: Leads and develops a high-performing team of scientists and researchers, fostering innovation and professional growth. Cross-functional Collaboration: Collaborates with various internal departments (Regulatory, Clinical, Marketing, etc.) and external partners. Regulatory and IP Oversight: Ensures compliance with regulations and manages the company's intellectual property strategy. Uphold the company’s core values of Integrity, Innovation, Accountability, and Teamwork. Demonstrate behaviour consistent with the company’s Code of Ethics and Conduct. It is the responsibility of every employee to report to their manager or a member of senior management any quality problems or defects for corrective action to be implemented and to avoid recurrence of the problem. Duties may be modified or assigned at any time to meet the needs of the business. Qualifications REQUIREMENTS: Education: Bachelor of Science in engineering/Biotechnology/Bio-Medical or equivalent with a minimum of 15+ years of medical product development experience. Management Experience: Minimum of 10 years prior engineering management experience with demonstrated ability to lead and manage people and teams. Regulatory Knowledge: Must be knowledgeable of FDA Design Control requirements. Vendor Management: Must have experience working with OEM vendors and outsourced development. Remote Management: Must have experience managing remote development activities. Change Catalyst: Must be comfortable and effective acting as a catalyst for change. Technical Skills: Must have experience in software, electrical, mechanical, and industrial design. Interpersonal Skills: Strong interpersonal skills, excellent formal and informal communication skills, innovative problem-solving skills, and strong facilitation skills are required. Performance Orientation: Candidate must be performance and results-oriented and be able to develop, motivate, and lead strong, effective teams. Remote Teams: Experience managing remote teams is desirable. Portfolio Management: Experience delivering a complex portfolio of products is desirable. Matrix Organization: Experience working in a matrix organization is desirable. Technical Requirements: Clearly outline the hardware, software, network, and security requirements for development. Physical Requirements : Standing: 10% Bending: Sitting: 80% Stooping: Reaching: Walking: 10% Lifting: (0 - 25lbs or 25 - 50lbs) It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented to avoid recurrence of the problem. NOTICE TO THIRD PARTY AGENCIES OSI Systems, Inc. and its subsidiaries (collectively “OSI”) does not accept unsolicited resumes from recruiters or employment agencies. If any person or entity, including a recruiter or agency, submits any information, including any resume or information regarding any potential candidate, without a signed agreement in place with OSI, OSI explicitly reserves the right to use such information, and pursue and/or hire such candidates, without any financial obligation to the person, recruiter or agency. Any unsolicited information or resumes, including those submitted directly to hiring managers, are considered and deemed to be the property of OSI. OSI Systems, Inc. has three operating divisions: (a) Security, providing security and inspection systems, turnkey security screening solutions and related services; (b) Healthcare, providing patient monitoring, diagnostic cardiology and anesthesia systems; and (c) Optoelectronics and Manufacturing, providing specialized electronic components and electronic manufacturing services for the Security and Healthcare divisions, as well as to external original equipment manufacturer clients for application in the defense, aerospace, medical and industrial markets, among others. Acknowledgement I have read the job description and understand the requirements and expectations of this position. I will review orientation and training requirements with my manager. I understand that my duties may change, as directed by my manager.
Overview JOB SUMMARY: The Quality Assurance Engineer shall provide leadership and support for QMS performance in many facets of business operations: Design Control To ensure the release of safe, effective and compliant medical devices, the Quality Assurance Engineer shall provide Quality System Design Control mentoring to ensure product design teams’ use of critical thinking. He or she shall be well versed in all aspects of Design Controls, Risk Management, Electrical Safety and all associated processes, policies, procedures, and records. He or she shall ensure that the proper activities are completed in a timely manner, performed and documented correctly, and readily offers guidance and support to ensure Quality System compliance. The Quality Assurance Engineer shall review all Engineering Change Orders and proposed changes or improvements to ensure sound engineering practice, effective and adequate design, product safety, and Quality System compliance. The Quality Assurance Engineer shall ensure that product Design Change activities move ahead in a timely and effective manner . Manufacturing The Quality Assurance Engineer shall monitor and ensure efficient and effective product manufacturing processes, facilitating adequate manufacturing work instructions, material control, nonconforming material handling, inspection, and finished goods handling. Material Review Board The Quality Assurance Engineer shall facilitate efficient and effective processing of Nonconforming Material Reports and Rework Orders. Process performance metrics shall be captured, monitored, and reported to ensure timely and effective MRB throughput and minimized quarantine back log. Installation and Service The Quality Assurance Engineer shall ensure that post-market activities ensure intended device performance. Service and support activities must be adequately documented, attention escalated to facilitate defect handling, and product performance and performance trends assessed to understand and drive improvement opportunities QMS Administration The Quality Assurance Engineers are responsible for conducting QMS administration activities, including Internal Quality Audits, Corrective and Preventive Action, Process Change Control, Exception Handling, process improvement and maintenance, supplier quality, external audit support, and related activities. Responsibilities RESPONSIBILITIES and GOALS: The Quality Assurance Engineer Shall Follow The Guidance Of RA/QA Management And Help Other Organizational Functions Understand And Fulfill Their Obligations To Meet Quality Objectives, Systemic Responsibilities, And Customer Requirements, As Defined By Executive Management In The Spacelabs Quality Policy. As Part Of Maintenance Of The Spacelabs Quality Management System, Quality Assurance Engineers Shall Take Part In Some Or All Of The Following Responsibilities: Ensure high quality of products and services, by implementing and maintaining the Quality Management System. Ensure that QMS activities are risk-based. Perform, report, and drive remediation from Internal Quality Audits and participate in third party audit and inspection activities (MDR, MDSAP, etc.). Routinely pursue more efficient and effective operations (continual improvement). Support the development teams of all business areas, working within the project teams on new or sustaining product development projects. Support the maintenance of the Essential Requirements Checklists / General Safety, Essential Requirements checklist and Technical Documentation Files. Assist with the compliance to changes to standards such as EN 60601-1, ROHS3, REACH, and Global regulatory requirements applicable to Spacelabs’ products. Provide Quality System guidance to his or her product design teams. He or she shall be well versed in all aspects of Design Controls, Risk Management, Electrical Safety and all associated processes, policies, procedures, and records. Collaborate with engineering to determine and execute engineering design and development planning in support of regulatory submissions. Review Engineering Change Requests and Engineering Change Orders to identify critical components, defects in drawings/schematics, effective and adequate design documentation, product safety, and Quality System compliance. Assist with the creation, maintenance, and performance of QMS change management tools: Corrective Action Reports (CAR’s), Preventive Action Reports (PAR’s), and Process Change Orders (PCO’s). Support the manufacturing teams of all business areas, working within the teams on new or sustaining product and process improvements. Shall review and approve Device History Record (DHR) deliverables to ensure that production activities comply with Mandatory Device Master Record (DMR) requirements. Perform Manufacturing floor walkthroughs based on 7S criteria to support improvements and collaboration. Facilitate efficient and effective processing of Nonconforming Material Reports and Rework Orders. Create and update quality system procedure to achieve continuous compliance to ISO13485, European MDD/MDR, and MDSAP. Assist in the preparation and submittal of registration applications. May assist in the preparation of IDE, 510(k), CE Mark, and other similar regulatory filings. Shall participate in cross-functional design teams to review all Design and Development Plans, Design Inputs, Design Outputs, V&V documents, and Design Changes including Defect Reports. Quality Assurance Engineers shall recognize potential impacts to health or device efficacy (“Safety Issues”), support criticality assessment needed to ensure the application of reasonable and required Risk Management, Verification and Validation, and adequate record-keeping practices. Upholds the Company’s core values of Integrity, Innovation, Accountability, and Teamwork. Demonstrates behavior consistent with the Company’s Code of Ethics and Conduct. Ensure that direct report(s) are trained and evaluated on their knowledge and adherence to the Company’s values, Code of Ethics and Conduct, and applicable compliance policies. It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects for corrective action to be implemented and to avoid the recurrence of the problem. Duties may be modified or assigned at any time to meet the needs of the business. Qualifications Bachelor’s degree in a Quality, Engineering, or related discipline (Computer/Software, Biomedical, Mechanical, Electrical). 5+ years related Quality / Engineering work experience. 3+ years of experience with medical device regulatory and quality and Quality Management Systems Experience maintaining Technical Files, GSRPCs, Risk Management Files, Usability Engineering Files, Design History Files, MVP's, and Change Control documentation. Experience with statistical analysis Knowledge of Software within a device or Software as a Medical Device (SaMD). Experience working with teams under design controls and during new product development to follow the QMS and comply with current regulations and standards. Proven ability to communicate effectively with staff at all levels of the organization. Self-motivated and organized. Desirable Experience acting as a Change Agent Experience with FDA 21 cfr 820, 21 cfr 11, 21 cfr 806, MDD, MDR, MDSAP, EN ISO 13485, EN ISO 14971, IEC 62366-1, EN ISO 15223, EN ISO 20417, EN 62304, Cybersecurity, IEC 60601-1, ISO 27001 and 14001 preferred. Creative problem solving, flexibility, and good negotiation skills. Some travel may be necessary both domestic and international, less than 5%.
Overview The Mechanical Engineer provides support for projects involving complex mechanical design and manufacture in the development of Spacelabs patient monitoring products. Responsibility includes design, testing, prototyping and simulation, and parts selection. The Mechanical Engineer must demonstrate the ability to be solutions-oriented, work hands-on, meet schedule goals, lead/be part of effective teams, and demonstrate take-charge qualities. Responsibilities Execute complex designs in the following disciplines: plastic injection molding, vacuum forming, machining, casting, stamping and sheet metal. Apply theoretical calculation to design in areas such as thermodynamics, fluid flow, or structural analysis by testing mathematical models to validate the capabilities and parameters of the design and prove the prototype will do as design indicates. Optimize development of project/product by trade-offs of schedule, development cost, tooling cost, product cost, functionality, reliability, and manufacturability to meet the goals and objectives of the company. Rigorous adherence to company and quality procedures and requirements. Prepare product requirements. Provide technical reports and presentations. Actively appraise technology and product concepts to keep product lines competitive and moving toward excellence by attending seminars, reading related articles and talking to vendors. Schedule own development activities. Uphold the Company’s core values of Integrity, Innovation, Accountability, and Teamwork. Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct. It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem. Duties may be modified or assigned at any time to meet the needs of the business. Qualifications Bachelor’s Degree in Mechanical Engineering; equivalent experience may be accepted; Master’s degree in Mechanical Engineering preferred Relevant mechanical design/test experience (e.g. min 5+ years for level 2, 8+ level 3 (Overall relevant experience determines level) such as: Experience designing medical products Experience using rapid prototyping devices Experience in SolidWorks and mechanical stress and thermal modeling Experience analyzing parts and assemblies in CAE applications, preferably CosmosWorks Knowledge of HALT and HASS Experience with design documentation process Ability to manage multiple, complex priorities within demanding timeframes. Strong problem-solving skills. Experience working positively and productively in a team environment. Must possess the ability to work effectively with internal and external resources as a part of the product development process. Strong communication skills, including excellent writing and presentation skills.