Staff Scientist, Clinical Sciences (m/f/d)

Stryker Leibinger GmbH & Co. KG; Freiburg im Breisgau; Hybrid; EUR 53,000 - 89,000; Full time

Job summary

Stryker is seeking a Staff Scientist to provide technical support across biocompatibility, cleaning, disinfection, and sterilization for reusable and single-use medical devices. You will develop compliant testing protocols and support regulatory submissions for new products and changes, coordinating with R&D, GQO, Regulatory, and Marketing.

The role requires deep regulatory understanding (FDA, GMP, ISO) and expertise in various sterilization modalities, with mentorship responsibilities and

Qualifications

• In-depth knowledge of FDA, GMP, ISO, and other medical device regulations.
• Experience with sterilization, cleaning, and disinfection validation principles.

Responsibilities

• Develop compliant testing protocols and support regulatory submissions for new products and changes.
• Coordinate projects with R&D, GQO, Regulatory, and Marketing.
• Interpret standards related to sterilization, cleaning, disinfection and biocompatibility.
• Mentor others and support quality issues including customer complaints and non-conformances.
• Lead development or revision of quality system procedures for Clinical Sciences.

Skills

Regulatory knowledge

Sterilization expertise

Biocompatibility

Test standards interpretation

Project coordination

Microsoft Office

Education

Bachelor of Science in Biology, Microbiology, Chemistry, or Biomedical Engineering

Tools

Microsoft Office

Job description

Work Flexibility: Hybrid or Onsite Job Description ***3 year fixed term contract***

The Staff Scientist will 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.

Technical Responsibilities

Independently develop compliant testing protocols and guidelines and support regulatory submissions for new product development and product changes of both terminally sterilized and reusable medical devices.

Independently coordinate and complete project deliverables in collaboration with cross functional groups such as R&D, Global Quality Operations (GQO), Regulatory, and Marketing.

Interpret, assess, analyze and apply international standards related to sterilization, cleaning, disinfection and biocompatibility.

Mentor others.

Support technical problems of significant scope and complexity; independently determine and develop approach to solutions. This may include support for quality issues such as customer complaints, adverse events, product field actions, and non-conformances.

Perform gap assessments to new or changing standards and mentor others.

Lead the development or revision of quality system procedures for Clinical Sciences. This may include serving as a divisional process owner (DPO).

Support internal and external regulatory audits as an SME.

Participate in Corporate wide projects or initiatives; this may include Corporate quality system workgroups.

Support Regulatory Affairs in interactions with FDA or Competent Authorities on topics pertaining to Clinical Sciences Train, provide direction and technical support to junior team members Support internal and external customer inquiries.

Business Responsibilities

Advance solutions by applying in-depth knowledge of customer needs, design inputs and technical areas of responsibility.

Apply detailed knowledge of with product’s intended use, clinical procedures, and manufacturing process.

Demonstrate developing financial acumen.

Apply knowledge of how test strategies impact development timelines and cost.

Apply awareness of cultural differences that may exist in business practices in global interactions and mentor others.

Med Device Compliance

Be proficient with and mentor others in usage of industry standards, including validation requirements and test strategies per applicable regulations.

Lead creation and refinement of documentation, such as sterilization evaluations, biocompatibility evaluations, and reusable device processing evaluations, per company design control procedures.

Follow and mentor others on procedures like terminal sterilization, biocompatibility evaluation, and reusable device processing, per the Quality Management System.

The role may include support of national and/or international standards committees and workgroups.

General Responsibilities

Work cooperatively with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success.

Identify and support the creation of or improvements to procedures, policies, processes, systems, and technology.

Support and execute complex projects on multifunctional teams to advance projects through the design /development/launch process.

Deliver high quality results with passion, energy and drive to meet business priorities.

Collaborate with cross-functional teams to build partnership to achieve business objectives.

Demonstrated leadership and interpersonal skills with ability to effectively communicate and lead through influence.

Preferred Qualifications

What you will need (strongly desired):

Technical Skills:

In depth technical knowledge and understanding of FDA, GMP, ISO, and other medical device regulatory requirements.

Adept at applying knowledge of cleaning, disinfection, and sterilization validation principles, testing concepts, standards, and practices within a regulated environment.

Strong technical expertise with multiple sterilization modalities (e.g, irradiation, ethylene oxide, vaporized hydrogen peroxide, moist heat).

Adept at applying knowledge of biocompatibility requirements, test methods, and practices within a regulated environment.

Adept at applying knowledge of environmentally controlled area qualification principles and monitoring requirements, standards, and practices within a regulated environment.

Ability to communicate moderate complexity plans and technical information to team members.

Strong technical ability to read and Interpret standards and regulations.

Strong technical ability to analyze and interpret laboratory and validation test results and to resolve test failures.

Working knowledge of business applications such as Microsoft Office.

Skills:

Exercise discretion and independence when applying professional expertise.

Must be able to manage time, projects, stress and conflict.

Must possess strong interpersonal skills including written and oral communication.

Must be able to bring tasks through to completion with minimal supervision.

Must have the ability to prioritize work and keep detailed and confidential records.

Must be able to communicate / present to large groups of people.

Certifications: AAMI CISS certification desirable.

Minimum Qualifications

What you will need (must have):

Education Requirements: Bachelor of Science in Biology, Microbiology, Chemistry, or Biomedical Engineering.

4+ years of work experience.

Germany Pay Ranges

Freiburg/Stetten 35Std: €4.760 - €7.965 EUR Monthly

Freiburg/Stetten 39Std: €5.305 - €8.875 EUR Monthly

Travel Percentage

10%

Company Overview

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility

Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.

Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.

Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements.

Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.