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

Senior Biocompatibility Engineer - 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

Roles and Responsibilities:

• 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
• Experience in regulatory and device regulations for medical devices including biocompatibility and regulated materials
• Effective verbal and written communication skills
• Ability to work well in a team environment
• The ability to work well under pressure
• The ability to evaluate, prioritize and manage multiple activities
• The flexibility to adjust work objectives to ensure the overall goals are met
• Demonstrated problem solving and critical thinking skills
• Technical understanding of the effect processing has on material properties and performance
• Ability to correlate material properties with product performance and predict various failure modes

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.