Staff Scientist

Portage, WI - USA

Monthly Salary: Not Disclosed

Posted on: 17 hours ago

Vacancies: 1 Vacancy

Job Summary

Work Flexibility: Hybrid

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 youll 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 youll 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 processingall 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

Bachelors 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

Masters 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

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer or (c) consistent with the contractors legal duty to furnish information.

Required Experience:

Staff IC

Work Flexibility: HybridStryker 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 youll play an integral role in driving innovation for new product development while also supporting s...

Work Flexibility: Hybrid

Stryker is hiring a Staff Scientist in Portage MI to join our Instruments Division supporting Surgical Technologies!

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

Bachelors 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

Masters 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

Travel Percentage: 10%

Required Experience:

Staff IC

Key Skills

Laboratory Experience
Bioinformatics
Biochemistry
Utility Locating
Assays
Research Experience
Next Generation Sequencing
Sensors
Signal Processing
Matlab
Research & Development
Molecular Biology

Apply Now

About Company

Stryker

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more

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