Job Description

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Senior Engineer, Advanced Operations to join our Stryker Instruments division in Kalamazoo Michigan.

Who we want

• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

What you will do

As the Senior Engineer, Advanced Operations you will provide process engineering support for sustainment and improvement of our surgical instruments, w orking with Marketing, R&D, Cost Accounting, and  Advanced Sourcing, Advanced Quality, and Validation team members.  They serve as the voice of operations in the development process and work on design for manufacturability and assembly. This position is responsible for process design, development, and validation in new product development.  Job responsibilities include:

• Working closely with internal and contract manufacturers to develop processes for electro-mechanical assembly including PCBA manufacturing, potting, conformal coating, soldering, pressing, laser welding, laser marking, torquing and manual assembly.
• Leads or support capital acquisition activity from specifying equipment, contract negotiation, installation, and validation. 
• 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. 
• Analyze equipment to establish operating data, conduct experimental test and result analysis.
• Lead and/or participate in process review meetings. 
• Participate in Process Failure Mode and Effect Analysis (PFMEA), Control Plan, SOP and Production Part Approval Process (PPAP) generation associated with product transfers and launches. 
• Complete capability studies for in process inspection and generate subsequent Inspection documentation.     
• Review and approval of validation documentation.

What you need

• Bachelor’s degree (B.S.) in Mechanical or Electrical Engineering or related engineering discipline required.
• 2+ years of experience in a manufacturing or R&D environment required.
• Understanding of Design for Manufacturing (DFM), Mechanical Fixture Design, Injection Molding, PCBA manufacturing, potting, conformal coating, soldering, pressing, laser welding, laser marking, torquing and manual assembly preferred.
• Experience in a FDA regulated or highly regulated industry preferred.
• Proven track record of working in a team-based environment. 
• Excellent interpersonal skills; able to express ideas and collaborate effectively with multidisciplinary teams.
• Innovative thinker; 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 electrical, mechanical and structural design. 

Job Tags

Similar Jobs