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. Stryker 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.

Stryker is looking to hire a Staff Engineer, Advanced Operations in Portage, Michigan to support new Stryker Surgical Products.

As the Staff Engineer, Advanced Operations you will have the opportunity to work on new product process development focusing on cutting edge surgical products. We are looking for a Staff Engineer with Electromechanical Assembly Experience, Risk Analysis, Design for Manufacturing & Validation experience.

WHO WE WANT:

• Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

• Self-directed innovators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

• 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. 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, data and insights to drive continuous improvement in functions.

WHAT YOU WILL DO:

As a Staff Engineer you will independently determine and develop approaches to a variety of technical problems of moderate scope and complexity. You will use the latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs. 

As the Staff Engineer, you will build productive internal and external working relationships and may periodically provide guidance and train other team members.

ADDITIONAL RESPONSIBILITIES INCLUDE:

• Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures.

• Ensure quality of process and product as defined in the appropriate operation and material specifications.

• Will 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.

• May lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.

• Will 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, Control Plan, SOP and Production Part Approval Process generation associated with product transfers and launches.

• Complete capability studies for in process inspection and generate subsequent Inspection documentation.   

• Conduct MSA studies for new products and new processes.

• Provide training for manufacturing team members.

• Ensure adherence to GMP and safety procedures.

• Review and approval of validation documentation.

• All other duties as assigned.

WHAT YOU NEED:

• ​​Bachelor’s degree in engineering required.

• 4+ years of related engineering experience required.

• Experience in an FDA regulated or regulated industry beneficial. 

• Good knowledge of manufacturing processes, materials, product and process design. 

• Must be able to read and interpret complex engineering drawings and can understand geometrical dimension and tolerances. 

• Experience in executing complex problem-solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design. 

• Good understanding of Design for Manufacturing related statistical tools and validation/verification techniques. 

ADDITIONALLY, YOU NEED:

• ​Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams. Be open minded with the ability to recognize good ideas. 

• ​Innovative thinker - should be able to envisage new and better ways of doing things. 

• ​ Proven track record of working in a team-based environment. 

• ​Excellent analytical skills, ability to plan, organize and implement concurrent tasks. 

• ​Certified in validation activities highly preferred.