Senior NPD Manufacturing Engineer

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 a technical STEM related field

• 2+ years of relevant experience

• Experience with process and fixture development

• Experience working with suppliers

Preferred Qualifications:

• Bachelor’s in Engineering

• 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.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.