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Why join Stryker?
Looking for a place that values your unique talents? Discover Stryker's award-winning culture. We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more: US Stryker employee benefits
Job description
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
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 and Orthopaedics 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.
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