Staff Scientist

Stryker•Portage, MI

3d•Hybrid

About The Position

Stryker is hiring a Staff Scientist in Portage, MI to join our Instruments Division supporting Surgical Technologies! As a key member of the New Product Development (NPD) team, you’ll play an integral role in driving innovation for new product development while also supporting sustaining activities to ensure continued product excellence and reliability. As a Staff Scientist, Clinical Sciences , you’ll be at the forefront of ensuring the safety and effectiveness of medical devices that improve lives worldwide. This is an opportunity to lead technical initiatives, influence global standards, and advance innovation in sterilization, biocompatibility, and device processing—all while collaborating with passionate experts across the organization.

Requirements

Bachelor’s degree in Biology, Microbiology, Chemistry, Biomedical Engineering, or a related scientific degree.
Minimum 4 years of experience in medical device or related regulated industry.
Proven knowledge of FDA and GMP standards.
Familiarity in sterilization validation principles and biocompatibility testing within a regulated environment.

Nice To Haves

Master’s degree in a related field.
Experience with multiple sterilization modalities (e.g., irradiation, ethylene oxide, vaporized hydrogen peroxide, moist heat).
Familiarity with ISO standards for medical devices (ISO 13485, ISO 10993, ISO 11135)
Familiarity with environmentally controlled area qualification principles.
AAMI CISS certification is desirable

Responsibilities

Be responsible for providing technical support to various areas of the business including biocompatibility, cleaning, disinfection, and sterilization of reusable and single use medical devices.
Collaborate closely with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success.
Develop and implement compliant testing protocols and guidelines to support regulatory submissions for new and existing medical devices.
Coordinate and deliver project milestones in partnership with cross-functional teams, ensuring timelines and quality standards are met.
Interpret and apply international standards for sterilization, cleaning, disinfection, and biocompatibility; mentor team members on best practices.
Lead investigations and resolve complex technical issues, including customer complaints, adverse events, and non-conformances.
Perform gap assessments on evolving standards and drive updates to quality system procedures.
Serve as a subject matter expert during internal and external audits and regulatory interactions.
Create and refine documentation for sterilization, biocompatibility, and reusable device processing evaluations in compliance with design control procedures.
Train and guide junior team members to build technical expertise and ensure consistent execution.