Manufacturing Engineer II

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

A Day in the Life

Responsibilities may include the following and other duties may be assigned:

• Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, machining, material handling, and processing.
• Create efficient and productive layouts by designing machine arrangements within plant facilities.
• Specify procedures and sequence of operations for fabrication tools, equipment, and production processes, ensuring optimal product performance.
• Collaborate with internal manufacturing sites and suppliers to design, characterize, and qualify high-capability processes for consistent product output, including process flows and control plans.
• Develop and maintain manufacturing processes aligned with statistical process control, risk mitigation (pFMEA), and regulatory requirements like ISO 13485 and FDA 21 CFR Part 820.
• Prepare and review validation plans, protocols, and procedures (IQ, OQ, PQ, MVR) for successful transfer activities.
• Inspect and troubleshoot machinery and equipment to maintain product quality, initiating corrective actions as necessary.
• Provide engineering support regarding design concepts, specification requirements, and best practices for manufacturing techniques.
• Present technical findings and project statuses to cross-functional teams and management.
• Adapt machine or equipment designs to factory and production conditions.
• Ensure that all processes and procedures comply with relevant regulations.

TECHNICAL SPECIALIST CAREER STREAM

An individual contributor responsible for advancing existing technology or introducing new technologies and therapies. You will formulate, deliver, and manage assigned projects, working with stakeholders to achieve desired results. You may also act as a mentor to colleagues or lead lower-level professionals. Most of your time will be spent on R&D and implementation of new technologies, from design to production, while adhering to Medtronic’s policies and utilizing your specialized knowledge and skills.

DIFFERENTIATING FACTORS

Autonomy:
You are an established, productive individual contributor who works independently with general supervision on larger, moderately complex projects or assignments.

Organizational Impact:
Your contributions will help achieve project milestones and may involve cross-functional collaboration.

Innovation and Complexity:
Problems and issues you face may require understanding broader sets of issues. You will make recommendations and improvements to systems and processes to enhance efficiency.

Communication and Influence:
You will primarily communicate with internal contacts and share information to inform decision-making. External communication is less frequent and usually related to problem-solving.

Leadership and Talent Management:
You may provide guidance and assistance to entry-level professionals or employees in the support career stream.

Must Have: Minimum Requirements

• Education: Bachelor’s degree in mechanical engineering or a related field with 5-8 years of relevant experience, or an advanced degree with 2+ years of experience in mechanical design, product development, or design verification/validation.
• Experience: Strong understanding of manufacturing process validation (Master Validation Planning, IQ, OQ, PQ) and Lean Manufacturing/Six Sigma methodologies.
• Skills: Proficiency in GD&T, interpreting mechanical drawings, and statistical analysis tools such as Design of Experiments (DOE). Experience with machining, molding, assembly processes, and risk management tools (pFMEA, dFMEA).

Nice to Have

• Medical device product development or manufacturing experience, with a solid understanding of FDA and ISO standards.
• Proficiency in CAD software like SolidWorks or similar for mechanical design and analysis.
• Experience across the entire product lifecycle, from design to manufacturing.
• Project engineering or program management experience.
• Strong problem-solving skills, with a focus on structured methodologies like Design for Six Sigma, DFMA, DRM, and Lean Manufacturing.

Physical Job Requirements

The physical demands described within this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers.

Benefits & Compensation

Medtronic offers a competitive salary and flexible benefits package. We are committed to our employees' well-being and success and recognize their contributions. We offer a wide range of benefits, resources, and compensation plans designed to support you at every stage of your career.

About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies, and services can do to help alleviate pain, restore health, and extend life. Join us and be part of a team that accelerates healthcare innovation.

Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.