Production Engineer I, II, III or Sr. (Days 8am to 5pm)
- Victor, NY
- $75,000-128,000 per year
- Permanent
- Full-time
- Provide technical support working closely with Team Leaders, Supervisors, and fellow Engineers, as needed. Ensures efficient operation of manufacturing processes within production; creates project plans, performs utilization studies, identifies capacity needs and constraints, and makes recommendations for improvements.
- Lead in the selection, installation, and validation of medical device process/packaging equipment utilizing project management tools, Risk Analysis/pFMEA, and Lean Manufacturing techniques.
- Assist in Preventive Maintenance (PM) procedures and executing PMs for cleanroom equipment and production equipment associated with packaging or production activities, as needed.
- Assist in writing and executing process qualification protocols and reports, as needed. Understanding of IQ, OQ, and PQ.
- Able to define, communicate, and develop fixture concepts using internal and external resources. Able to incorporate the capabilities of typical production association into these concepts.
- Prepares product and process reports by collecting, analyzing, and summarizing information and trends.
- Review of component designs and identification of Design for Manufacturing and Assembly (DFMA) opportunities. Able to identify critical component functions and determine which manufacturing techniques will provide the optimal outcome.
- Responsible for proper installation of new equipment and setting up proper preventive maintenance and calibration plans.
- All responsibilities listed above.
- Responsible for developing detailed process qualification strategies. Able to define statistical sample sizes as related to variable and attribute data, based on established company and industry standards.
- Advanced experience Design of Experimentation methodology and statistical analysis tools.
- Review of proposed component tolerances and input to manufacturing capability. Understands GD&T and how to properly apply it to yield the desired fits between joining parts.
- Responsible for developing detailed Process FMEAs and using the output to develop robust manufacturing processes. Also using the output to determine in-process testing and product final inspection requirements.
- Must be able to manage multiple projects simultaneously.
- Must be able to support alternative shifts, as needed.
- Maintains accurate and compliant documentation to meet company, and regulatory expectations.
- Provides direction and helps prioritize Production Technician tasks.
- Accomplishes all other duties and tasks as appropriately assigned or requested.
- B.S. Degree in mechanical, manufacturing, industrial engineering or similar technical field or 2-year technical degree with 4 to 7 years of relevant manufacturing experience.
- Experience in a medical device/pharmaceutical manufacturing (or similar highly regulated industry) preferred.
- B.S. Degree, with a minimum 8+ years’ work experience in Manufacturing Engineering with 4 + experience in the medical device or pharmaceutical industry (or similar highly regulated field).
- Familiar with manufacturing efficiency strategies such as Lean, Six Sigma, 5S, Value Stream mapping, etc.
- Experience in Design for Manufacturing, FMEA, DOE, and Validations.
- Understanding of ergonomics as related to repetitive stress injuries.
- Experience using 3D CAD Design Software preferred
- Problem solving and decision-making skills are necessary and ability to work independently and with a team including working knowledge of Problem – Issue – Opportunity board or similar issue tracking/containment tool.
- Attention to detail and tasks being performed in order to identify potential changes and/or problems with the processes and products.
- Creates Project Plans and organizes resources to ensure project milestones are met within expectations of timeline, quality, and budget.
- Frequently required to lift, carry, push and/or pull from 30-50 lbs.
- Ability to periodically climb and use color vision/depth perception.
- Sitting, standing and/or walking for up to eight hours per day.
- Frequently communicates with other departments who have inquiries about projects, packaging specifics and sterilization procedures. Must be able to exchange accurate information in these situations.
- Bonus Plan, 401(k) plan with company match, Tuition Assistance, Employee Assistance Program (EAP) and Product Discounts
- 15 Paid Holidays, PTO, Sick Time
- Medical, Vision and Dental effective first day of employment
- Employee Referral Bonuses