What you will do:
As a Senior NPD Manufacturing Engineer, you will support the design transfer of products from R&D to Service. In this role, you will collaborate with cross-functional teams in both technical and non-technical capacities to successfully launch servicing of new products. You will also be responsible for developing and qualifying the repair process for medical devices at Stryker.
Use latest engineering techniques to provide design and process inputs for serviceability whilst adhering to regulatory requirements, project deadlines and product costs.
Analyze, determine, and advocate for service model that best meets the needs of our customers and business.
With minimal guidance determine and develop approaches to a variety of technical problems of complex scope and complexity.
Build productive internal and external working relationships and may periodically provide guidance and train other team members.
Lead engineer for launching servicing of new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product and service development procedures.
Ensure quality of process and product as defined in the appropriate operation and material specifications.
Provide input on components and equipment based on analysis of specifications, reliability and servicing requirements. Work with quality engineers to develop component specific testing and inspection protocols.
Analyze equipment and process to establish servicing parameters and criteria. Lead and/or participate in process review meetings.
Participate in PFMEA, Control Plan, SOP and PPAP generation associated with service product transfers and launches.
Execute, review and approve complex validation of new equipment or new processes.
Introduce new service manufacturing technology and service commercial offerings
Work closely with service sustaining to transfer engineering test procedures to manufacturing test procedures
Ensure adherence to GMP and safety procedures.
Minimum Requirements:
Bachelor’s Degree in Engineering
2+ years of relevant experience
Experience with process and fixture development
Experience working with suppliers
Preferred Qualifications:
Knowledge of applicable domestic and international regulations and quality system standards – FDA QSR, MDD, ISO13485, ISO9001, etc.
Experience in independently executing moderately complex problem-solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design.
Solid analytical skills, ability to plan, organize and implement concurrent tasks.
Proven ability to handle multiple assignments at once while meeting all deadlines
Must be able to routinely make decisions which affect immediate operations.
Demonstrated ability to plan, track and facilitate projects.
Preferred understanding of Quality Management System tools, Six Sigma tools, problem solving, root cause analysis, Lean and continuous improvement methodologies, with proven ability to apply them.
United States of America Pay Ranges:
- US30: $101,000 - $168,400 USD Annual
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 contractor’s legal duty to furnish information.
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.
