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Company

Original Job Post

Stryker · 3 days ago

Staff Biocompatibility Engineer/Scientist

Memphis, TN

Full-time

Remote

Senior Level

$86K/yr - $182K/yr

5+ years exp

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Responsibilities

Provides support and directions to other engineers and scientists in the field of Biological Sciences. Partners with cross-functional project team members to define evaluation / verification strategies of medical devices.

Works with minimal supervision, conferring with superior on unusual matters. Assignments are broad in nature, requiring originality and ingenuity.

Plan, execute, evaluate, and document biocompatibility studies and justifications in support of product safety and performance tests.

Develop technically sound test campaigns, protocols, reports, regulatory summaries, and verification of methods and results in collaboration with project team, test laboratories, and suppliers.

Review, evaluate, interpret, and apply internal and external guidance documents as they relate to biocompatibility.

Make positive contributions, recommend approaches, and support updating / developing internal procedures that comply with applicable global regulatory requirements.

Oversee subject matter expertise related to international standardization (ISO, ASTM, FDA guidance, others) and implement requirements into guidelines.

Identify and analyze materials, design, and process challenges to achieve optimal solutions that satisfy cost and technical requirements as they relate to biological safety.

Responsible for identifying critical process factors and their effects on biological safety.

Develop and execute project plans to include definition of scope, timelines, critical path management, resources, and budget as they relate to biocompatibility.

Interface with key business partners and represent biocompatibility team on new product development teams.

Manage external test campaigns (i.e. biocompatibility and chemical testing).

Initiate and communicate best practices and methodologies with Biological Sciences team and cross-functional team members, as appropriate.

Provide technical leadership to interns, technicians, specialists, scientists and engineers related to Biological Sciences.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Biological SciencesBiocompatibilityISO StandardsComplianceBiological EvaluationISO 10993Verification/validation testingDesign controlsRegulated industry complianceProject planningTask dependenciesExcelPowerPointWordData analysisTechnical recommendationsWork team collaborationProblem-solvingHard-workingTeam-orientedMotivatingAnalyticalDetail-oriented communicationInterpersonal skillsLeadership

Required

Bachelor's Degree in Engineering or a Science is required

Minimum of 5 years in a Biological sciences, biocompatibility, Quality or Regulatory role in the medical device industry

Possess knowledge and understanding of biocompatibility-related processes and contamination controls, principles, practices, and procedures of the field including ISO standards and compliance

Direct experience in biological evaluation of medical devices per ISO 10993

Preferred

Bachelor's Degree in Engineering or Science with a focus in Chemistry or Biological Sciences preferred

Demonstrated ability to successfully contribute to and lead complex verification / validation test campaigns

Demonstrated ability to apply design controls within a regulated industry

Demonstrated knowledge and ability to apply fundamental and advanced concepts, practices, and procedures regarding biocompatibility

Capable of developing and driving to a detailed project plan with scheduled and defined dependencies between tasks and deliverables

Must be team oriented, with the ability to motivate and work well with diverse cross-functional teams

Must possess strong analytical skills and be detail oriented

Must be computer proficient in Excel, Project, PowerPoint, Word, etc

Demonstrated ability to draw conclusions, present and make recommendations based on analytical data and technical inputs from multiple and varied functions (i.e. Manufacturing, Quality, Regulatory, Design, Sourcing)

Excellent communication skills, both verbal and written, and interpersonal skills to effectively and professionally interact with and contribute constructively to a global team environment, outside departments and externally

Demonstrated ability to lead complex initiatives from concept through release

Demonstrated ability to achieve work objectives both independently and as a leader/member of a work team

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

Glassdoor

4.1

Stryker is a medical technology company that offers products and services in orthopaedics.

Founded in 1941

Kalamazoo, Michigan, USA

10,001+ employees

http://www.stryker.com/en-us/index.htm

H1B Sponsorship

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2020 (69)