Stryker · 14 hours ago
Sr Staff Scientist
Portage, MI
Full-time
Onsite
Senior Level, Lead/Staff
6+ years expStryker is hiring a Sr Staff Scientist in Portage, MI to join their Instruments Division supporting the Neurosurgical business unit. This role involves driving innovation for new product development and ensuring the safety and effectiveness of medical devices, while collaborating with various teams to support regulatory submissions and maintain product excellence.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
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
Qualification
Required
Bachelor's degree in Biology, Microbiology, Chemistry, Biomedical Engineering, or a related scientific degree
Minimum 6 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
Preferred
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
Benefits
Medical and prescription drug insurance
Dental insurance
Vision insurance
Critical illness insurance
Accident insurance
Hospital indemnity insurance
Personalized healthcare support
Wellbeing program
Tobacco cessation program
Health Savings Account (HSA)
Flexible Spending Accounts (FSAs)
401(k) plan
Employee Stock Purchase Plan (ESPP)
Basic life and AD&D insurance
Short-term disability insurance
Company
Stryker
Stryker is a medical technology company that offers products and services in orthopaedics.
10001+ employees
H1B Sponsorship
Stryker has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Leadership Team
Kevin Lobo
Chair & CEO
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase