The Role
Provide engineering support for product transfers, ensuring compliance with procedures, mentoring others, and maintaining quality standards in manufacturing processes.
Summary Generated by Built In
Work Flexibility: HybridKey Areas of Responsibility
- Provide engineering support for product transfers ensuring that all activities are completed and documented in accordance with the latest Stryker procedures.
- Determine the technical objectives of engineering assignments and makes decisions regarding the direction and the results of the assignment.
- Monitor and control progress of work ensuring sound application of engineering principles and the appropriate use of policies and procedures.
- Analyse equipment to establish operating data, conduct experimental test and result analysis. May lead or act as independent reviewer in process review meetings.
- Coach and mentor others on functionally related topics.
- Ensure quality of process and product as defined in the appropriate operation and material specifications.
- Select components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols.
- Participate in PFMEA, Control Plan, SOP, PPAP and other Stryker internal process qualification generation associated with product transfers.
- Ensure adherence to GMP and safety procedures.
- Review and approve of validation documentation.
- All other duties as assigned.
- Bachelors degree in an engineering discipline with 2 or more years’ experience in a manufacturing or project environment
- Proven track record of working in a team based environment.
- Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams. Be open minded with the ability to recognise good ideas.
- Innovative thinker - should be able to envisage new and better ways of doing things.
- Experience in executing complex problem solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design.
- Experience in executing complex problem solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design.
- Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing.
- Experience in an FDA regulated or regulated industry
- Experience of process/ product validations, statistical methods, Process mapping,
- Continuous Improvement and Project / Process Improvement related experience
- Green or Black Belt 6 Sigma qualifications
- Experience in an FDA regulated or regulated industry beneficial.
Top Skills
6 Sigma
Engineering Principles
Fda Regulations
Gmp
Process Mapping
Statistical Methods
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The Company
What We Do
Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases.
