Staff Engineer, Advanced Operations

Work Flexibility: Hybrid

Who we want-

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

Stryker's Sustainability Solutions Advanced Operations team is seeking to hire a Staff Engineer, Advanced Operations to work on new product introduction process development in Chandler, Arizona.

What you will do-

• Serve as project coordinator, specifically aligning work and people to ensure project success.
• Provide engineering support and leadership for product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker product procedures
• Ensure quality of process and product as defined in the appropriate operation and material specifications
• Lead the specification, development and implementation of manufacturing equipment based on analysis of specifications, reliability and regulatory requirements
• Analyze equipment and processes to establish operating data and conduct experimental test and result analysis
• Lead and participate in process review meetings
• Evaluate process layouts in terms of supporting new process integration while ensuring best utilization of floor space ensuring optimum process flow
• Lead and participate in process failure mode and effect analysis (PFMEA), control plan, standard operating procedures (SOP) and production part approval process (PPAP) generation associated with product transfers and launches
• Conduct process validations and measurement systems analysis (MSA) studies for new products and new processes
• Review and approve validation documentation
• Drive and execute effective communication with all stakeholders to enable project success
• Identify and support the creation of or improvements to procedures, policies, processes, systems, and technology
• Be proficient with and mentor others in usage of industry standards, including design requirements and test strategies per applicable regulations
• Lead creation and refinement of engineering documentation
• Provide training for manufacturing team members
• Ensure adherence to good manufacturing practices (GMP) and safety procedures

What you need-

• Bachelor's degree in engineering or related field required
• A minimum of 4+ years of relevant work experience required
• Strong technical ability to develop and optimize designs to incorporate design for manufacturability (DFM) principles required
• Experience with engineering development, including installation qualification, operational qualification, performance qualification (IQ/OQ/PQ), or equivalent experience required
• Good knowledge of manufacturing processes, materials, product and process design required
• Experience in developing and implementing manufacturing processes and equipment required
• Ability to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing (GD&T) - highly preferred
• Experience planning, reviewing and executing process validations- highly preferred
• Six Sigma Green Belt or higher - highly preferred
• Experience in a FDA regulated or medical device and/or biotech field -highly preferred

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.