Work Flexibility: Onsite

The Senior Manufacturing Engineer will work with internal global operations and/or suppliers to ensure optimized processing is in place from raw material sourcing through final packaging validation.  The position will also focus on commercialized product maintenance and lead continuous process improvement and lead-time reduction activities ensuring proper change control is followed.

Essential Duties & Responsibilities:

Achieve business objectives: support quality speed to market, planning & control of manufacturing cost, process risk management, cycle time reduction, and new supplier validations.Achieve business objectives: support quality speed to market, planning & control of manufacturing cost, process risk management, cycle time reduction, and new supplier validations.Interface with key business partners and represent manufacturing on new product introduction teams.Complete verification and validation master plans for supplier qualification and / or certification.  Lead validating specialized processes (cleaning, sterilization, biocompatibility, porous and plasma coating, additive manufacturing, etc.).Orthopedic manufacturing process development (Master routes, BOM’s, defining inspection criteria, cleaning, packaging, labeling) and supplier control plans.Support and sustain harmonized US packaging and labeling systems and processes: design, layout, approval, release, and printing.Responsible for sustaining manufacturing BOM’s, item cards, routings, engineering change review, NCE’s, CAPA’s and process specifications.

Minimum Requirements:

Bachelor’s degree in engineering field or related discipline. 2 plus years of experience of manufacturing, cleaning, inspection, packaging, and labeling processes.

Preferred Qualifications:  

Knowledge of Product Lifecycle Management, Unique Device Identification, Direct Part Marking.Knowledge of additive and/or subtractive manufacturing processes.Knowledge and experience working with ISO 14971, 13485, 14971, 10993 and 21CFR Part 820 regulations.Demonstrated use of quality tools (Statistics, Lean, Six Sigma, DOE, etc.)Analyze and interpret engineering drawing specifications per ANSI 14.5 and established drafting standards.Project Management skills.CNC knowledge

Travel Percentage: 20%

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.