Position Summary:The Senior Manufaturing Process Engineer to champion daily manufacturing performance and long-term operational improvements. This role is deeply embedded on the production floor-driving process capability, refining tooling and process concepts, mentoring technical staff, and enabling cost-effective, high-quality production. You will oversee technical projects from early definition through implementation, always with an emphasis on practical improvements that stabilize, simplify, and enhance manufacturing operations.
PRIMARY RESPONSIBILITIES:- Promote a safety first mentality for all production areas, equipment, processes, and procedures.
- Provide guidance and day-to-day direction to technicians and engineers on assigned activities and best practices.
- Utilize lean process technology and automation during manufacturing execution to continuously improve the manufacturing environments driving cost leadership, world-class quality, and customer satisfaction.
- Collaborate with new product introduction teams to ensure seamless implementation of new process flows and assist with transfer activities.
- Complete projects, report status, and document lessons learned efficiently; utilize project management tools to establish timelines, action item lists, assignments, due dates, and milestones.
- Lead process validation activities, including IQ, OQ, and PQ for equipment, tooling, and processes.
- Develop/improve processes and sampling activities, as well as tooling and manufacturing concepts that meet customer expectations on cost, quality, and delivery.
- Lead process improvement and waste elimination efforts through the application of lean principles; actively participate in continuous improvement events.
- Conducts DOE studies, process characterization, and root-cause analysis to establish and maintain robust process windows.
- May communicate with existing customers on changes to existing processes, conveying timelines, and managing validation activities related to the change.
- Apply statistical tools to establish/monitor capability and verify effectiveness of improvements.
- Lead investigations and drive NCR/MRB/CAPA actions to closure in partnership with Quality and Operations; execute approved changes via change control.
- Demonstrates all corporate values
- We think and act like owners.
- We are bold in our aspirations while moving forward with humility and integrity.
- We are committed to making our customers successful.
- We foster inspired teams
Minimum Qualifications:- Bachelor of science in a related engineering field from a four-year college or university.
- 5+ years of engineering experience within a medical device or contract medical device manufacturing environment.
- Working knowledge of typical medical device manufacturing techniques (tipping, thermoplastic injection molding, and extrusion).
- Proficiency in Microsoft Word, Excel, PowerPoint, and Minitab (or other statistical analysis software).
- Proven experience leading IQ/OQ/PQ and working to ISO 13485 / FDA 21 CFR 820.
- Practical experience using DOE, SPC, and Gage R&R; familiarity with control plans and PFMEA.
- Must have advanced skills in Microsoft Word, Excel, PowerPoint, and Minitab (or other statistical analysis software). SOLIDWORKS or CAD modeling software is a plus
- Analytical and problem-solving skills; detail-oriented and able to produce accurate, professional documentation.
- Motivated and creative; operates effectively under pressure in a fast-paced team environment.
- Excellent interpersonal skills with the ability to communicate needs and demands effectively.
- Drives continuous improvement and waste elimination through lean principles.
Physical Demands:- The employee may be required to lift and/or move up to 25 pounds
- The employee may be required to sit for extensive periods.
Work Environment:- The job is performed indoors in a variety of settings, including the office, manufacturing floor, and warehouse. Exposure to loud noises, dust, and dirt may occur. Protective safety clothing/gear may be required. Activities include extended periods of standing or sitting and extensive work with measuring devices and other machinery.
Special AccommodationIf you are a person with a disability and need assistance applying for a job, please submit a request.
