We anticipate the application window for this opening will close on - 3 Oct 2025

 

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

The Senior Product Engineer is responsible for leading biological evaluations within a risk management framework, ensuring compliance with ISO 10993 standards and global medical device regulations. This role involves conducting comprehensive biocompatibility assessments, organizing and coordinating required testing, and authoring clear, concise, and well-structured biocompatibility evaluation plans and reports to support regulatory submissions.

The Senior Product Engineer applies scientific rigor in analyzing and characterizing materials, designs, and devices, and demonstrates strong critical thinking, problem-solving, and decision-making skills. The role requires the ability to produce high-quality technical documentation and effectively communicate findings.

This position also involves close collaboration with multidisciplinary and cross-functional teams to ensure compliance with global chemical safety regulations (e.g., EU MDR, Prop 65, CLP, REACH), particularly in support of Materials of Concern assessments.

In addition, the Senior Product Engineer contributes to scientific efforts in a research and development environment, including the preparation of technical protocols and reports, as well as drug compatibility studies related to biocompatibility evaluations.

The role also supports product development by designing and executing design verification test methods and conducting statistical data analysis to assess product performance and functionality. The candidate is expected to contribute to scientific presentations and author relevant technical publications as needed.

This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.

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

• Acquire working knowledge of ISO 10993 standards for biocompatibility. Maintains knowledge of the latest standards, regulations, and research in biocompatibility.

• Provide technical documentation concerning biological assessments of material and device safety per ISO 10993-1. Conduct biocompatibility impact assessment for changes on materials, processes, or intended uses of devices. Job includes coordinating and overseeing biocompatibility testing with external laboratories and analyzing test results to ensure compliance with regulations.

• Perform technical feasibility and design verification activities in a product development environment viz. biocompatibility, toxicological risk assessments, materials of concern (MOC), and insulin compatibility, either independently or in collaboration with department staff/contract test laboratories. Biocompatibility responsibility includes understanding chemical characterization data such that it integrates with biological evaluation report (BER).

• Liaise with internal (manufacturing, regulatory, quality, product development, supplier quality, post market surveillance, clinical) and external contacts (contract research organization (CRO), suppliers of raw materials and semi or finished products) to collect all the relevant information, and to ensure biocompatibility considerations are integrated into the product lifecycle.

• Where necessary, prepare devices for submission to internal and external test laboratories, maintaining good documentation practices. Document and maintain records of original information.

• Assist more senior members of the team in updating procedures, internal processes, data collection, report writing and standard gap assessments.

• Conducts exploratory research to produce new knowledge and potential products; conceives, organizes, promotes, and executes ideas and plans to new subcutaneous infusion devices.

Minimum Requirements: 

• Requires a Bachelors degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Nice to Haves:

• BS in science, medical technology, or related fields. MS or PhD preferred.

• Strong understanding of ISO 10993 and global medical device regulations (e.g., EU MDR, FDA, REACH, Prop 65). 

• Experience with biocompatibility assessments, toxicological risk evaluation, and material characterization. 

• Experience with analytical techniques (e.g., LC, GC, MS) and drug compatibility testing. 

• Knowledge of design control, risk management, and design verification/validation processes. 

• Strong technical writing, data analysis, and statistical evaluation skills. 

• Effective cross-functional collaboration and project management capabilities. 

• Experience in designing and developing medical device products 

• Strong skills in design of experiments, data analysis, written and verbal communications, and collaboration 

• Critical thinking skills to Interpret available data and recommend strategies to resolve technical challenges 

• Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects  

• Author, execute, review, and approve protocols, reports, and/or regulatory submissions pertaining to biocompatibility and/or clinical evidences 

• Provide objective assessment through critical review, interpretation and analysis of raw data, clinical relevance, toxicological risk assessments and trending 

• Extensive knowledge in analyzing and solving problems in a disciplined fashion, ensuring clear understanding of the root cause(s) and efficient recommendations for resolution 

• Must be self-motivated and able to multi-task, meet tight deadlines and prioritize changing demands in a fast-paced environment 

• Energetic, enthusiastic, and enjoys the challenge of creative design 

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. 

The physical demands described within the Responsibilities section of 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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

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.
 

Salary ranges for U.S (excl. PR) locations (USD):$102,400.00 - $153,600.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

 

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

 

Regular employees are those who are not temporary, such as interns.  Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

 

Further details are available at the link below:

Medtronic benefits and compensation plans

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.

Learn more about our business, mission, and our commitment to diversity here.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.