Staff Engineer, New Product/Process Development
StrykerAbout the role
At Stryker’s Sage division, we develop innovative products that help prevent hospital-acquired conditions — including ventilator-associated events, pressure injuries, skin damage due to incontinence, surgical site infections, and healthcare worker injury.
What You Will Do:
As a Staff Process Development Engineer, you will play a key role in bringing new products from concept through commercialization. You will lead the development of robust, scalable, and automated manufacturing processes that support Sage’s growing product portfolio.
You will:
Lead manufacturing process development for new product introduction (NPI) programs from design transfer through launch.
Identify and implement best-in-class automation and manufacturing technologies to improve quality, throughput, and cost.
Own capital equipment projects, including equipment specification, vendor selection, contract negotiation, installation, and validation.
Develop project plans, cost estimates, and resource strategies to deliver on time and within budget.
Drive process validation activities (IQ, OQ, PQ) and ensure compliance with regulatory and quality system requirements.
Partner cross-functionally with R&D, Quality, Operations, and Supply Chain to ensure seamless product launches.
Lead risk assessments and manufacturing documentation, including PFMEA, Control Plans, SOPs, and PPAPs.
Apply Lean and advanced engineering methodologies to reduce time to market while optimizing cost and performance.
Minimum Qualifications:
Bachelor’s degree in Engineering (Mechanical, Industrial, Biomedical, Electrical, or Controls preferred; other technical degrees considered with relevant experience).
4+ years of manufacturing experience in medical device, automotive, pharmaceutical, food, or other highly regulated industries.
Preferred Qualifications
Master’s degree in Engineering or related field.
Hands-on experience developing and scaling automated, high-speed manufacturing processes.
Experience with plastic molding, ultrasonic/RF welding, sealing, thermoforming, or sewing technologies.
Lean Six Sigma Green Belt or Black Belt certification.
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