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Job description
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.
What You Will Do
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.
What You Will Need
Required Qualifications
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.
Preferred Qualifications
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
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
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