Senior Biocompatibility Engineer at Medtronic in Philadelphia, Pennsylvania

Job Description:

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 individual in this position will develop and execute the biocompatibility analysis of medical device products, supporting the regulatory submission of both implantable and non-implantable Medtronic product. This person will work under general supervision, assembling current design documentation, providing gap assessments and strategies to remediate in accordance with international standards and European medical device regulations.

Provide assessments of existing and new medical device product against current medical device regulations and international standards.

Determine activities needed to remediate medical device product biocompatibility and hazardous substance data to current requirements.

Document compliance of product to internal procedures.

Support the quality and reliability of released product through comparative testing or root cause characterization testing.

Participate in the analysis of technical issues and the development of recommendations for project decisions and actions

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

• Responsible for biological safety assessment in compliance with ISO 10993, FDA, and other geographical requirements for medical devices.


• Provides guidance in the development of products and selection of materials to ensure that released products meet biological safety requirements.


• Uses applicable standards, written procedures, statistical processes, and academic understanding of toxicology and biocompatibility principles to accomplish tasks.


• Authors biocompatibility evaluations and/or toxicological risk assessments for regulatory submissions and compliance by analyzing, interpreting, and drawing conclusions from biocompatibility testing, extractable and leachable chemical characterization, and biological evaluations.


• Leads team in product failure investigations, interacting across functions and management levels.


• Engages in continuous improvement activities aimed at increasing efficiency and productivity, contributing to the overall operations and to the achievement of organizational goals.


• Maintains substantial knowledge of state-of-the-art principles and theories and may contribute to scientific literature and conferences.

Requires a Baccalaureate Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience. (For degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. • 214.2(h)(4)(iii)(A)).

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):$108,800.00 - $163,200.00

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).

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 90,000+ 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.

At Medtronic, most positions are posted on our career site for 3-7 days.