Job
Description
The research we do and the products we develop improve outcomes for patients around the world. As a Sr. Engineer, Risk at Vantive, your work supplies directly to making a significant impact on others. Its ambitious work and youre not on your own. Our teams collaborate multi-functionally and lead by influence. Job Responsibilities: Responsible for leading the activities associated with the Risk Management of products in various stages of the product lifecycle from new product development to post-market surveillance. Provides ongoing risk analysis and identification of required risk mitigations to ensure a safe, effective product. Responsible for identifying risks and helping define requirements and verification & validation testing to mitigate risk Drive completion of Risk Management activities towards design transfer and successful commercialization of new products. Provides leadership and subject matter expertise to product development teams to ensure Risk Management principles are applied throughout the development cycle. Creates and approves Design History File deliverables associated with Risk Management. Assesses and improves the Risk Management process. Facilitate an improved understanding of the interrelationship between Risk and Reliability. Expedite, manage, and coordinate interrelated Risk Management activities across functions, within the constraints of human and financial resources and changing priorities. Participate in identifying and planning tasks, activities, and resourcing needs related to Risk Management. Collaborates with Engineering, Manufacturing, and Service organizations in the development of design FMEA, Process FMEAs, and roll-up into Risk Management files. Working knowledge of FMEAs and standards applicable to Reliability Engineering (e.g. IEC 60812). Recognizes strategy, evaluates risks, recommends actions, and develops contingencies to address various scenarios. Able to analyze risk/tradeoffs and make recommendations of the appropriate path forward. Motivates and successfully influences stakeholders and cross-functional team members within the project. Qualifications/Experience: BS/MS degree in Engineering, with approximately 3-5 years of practical Electromechanical Medical Device Design experience. Able to effectively manage and lead complex projects. Has led the Risk Management activities of at least one significant project. Six Sigma Green belt or Black Belt (DFSS) certification preferred; LEAN certification preferred Must have a good working knowledge of regulations and standards affecting medical devices and have experience with products under design controls, documentation controls, risk management, and validation. Knowledge of Medical Device regulations (21CFR820, European MDD, Canadian Medical Device regulations, etc.). Understanding and application of the standards related to Risk Management and Reliability: (e.g., ISO 13485, ISO 14971, IEC 60812, IEC 61025, IEC 62366, IEC 60601, IEEE-1633, etc.). Membership and/or certification in a professional organization a plus (e.g. INCOSE). Experience working with Agile program methodologies Knowledge of Medical Device regulations (21CFR820, European MDD, Canadian Medical Device regulations, etc.). Understanding and application of the standards related to Risk Management and Reliability: (e.g., ISO 13485, ISO 14971, IEC 60812, IEC 61025, IEC 62366, IEC 60601, IEEE-1633, etc.) Experience developing requirements based on risk for products and/or process Strong experience in Requirements Management, Configuration Management, Defect Tracking and Traceability Experience leading collaboration and problem solving with globally located cross-functional representatives team members Experience in resolving complex technical problems using strong analytical skills Vantive is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $88,000- 105,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
