At our facility in Denver, PA you will be responsible for manufacturing engineering activities associated with assigned technology / product lines, including: quoting, process & equipment development and maintenance, documentation, qualifications and validations, training and technology transfer, improvements, hands-on assistance, project management and process innovation.

The successful candidate:

• Collaborates with Engineering, Quality, Supply Chain, Manufacturing, Finance, & Sales to create quotes, designs, drawings, processes, and work instructions; acts as a subject matter expert for manufacturing processes.

• Performs design reviews that incorporate a detail-oriented perspective on the impact of specific, dimensional accuracy and overall integrity of produced parts, components, sub-assemblies, and finished medical devices.

• Develops, implements, and maintains methods & routings in the fabrication and assembly of parts, components, sub-assemblies, and final medical devices.

• Estimates manufacturing cost using time standards and makes recommendations for tooling and process requirements of new or existing product lines.

• Participates in analysis, reviews, & transfers to manufacturing as it relates to development of the manufacturing processes, post processing development, equipment and process validations, process definition for machine operation and maintenance requirements, test/inspection methods, fixturing, gauges and applying inspection and process control techniques.

• Drives implementation of manufacturing processes that require qualification and/or validation of new equipment or processes. Creates and/or collaborates on PFEMA, IQ, OQ & PQ compliant with existing SOP's.

• Manages and works on projects.

• Maintains records and reporting systems for coordination of manufacturing operations.

• Develops and leverages knowledge to assist the production department to become more efficient. This individual works cross functionally with managers, engineers, technicians, and operators to ensure programs and products run smoothly.

• Conducts training sessions with new employees, carries out on-the-job training as associated with assigned product line responsibility.

• Sets up and operates production equipment as needed to either troubleshoot programs, prove out processes or perform engineering studies.

• Solves maintenance problems and implements solutions as associated with assigned product lines.

• Collaborates with suppliers or vendors on technical issues and new product introductions.

• Executes Engineering Change Process and implements process updates and improvement efforts.

• Translates new expertise or process innovation concepts into IP, recognized, implemented, and valued by the business.

• Develops business processes and metrics and tracking tools for deliverables the department is responsible for completing.

• Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to role.

• Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties.

• Maintain communication with manufacturing on established products concerning changes, revisions, problems, and improvements and take necessary actions.

• Adheres to all Company policies, rules, procedures, and housekeeping standards. Follows the official policy for Good Manufacturing Practices as required in the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act.

Other duties may be assigned.

Bachelor’s degree (BS) from four-year college or university; or fifteen years related experience and/or training; or equivalent combination of education and experience.

Additionally,

• 5-7 years of experience with CAD/CAM software and tooling to create CNC programs
• Demonstrated ability and fluency in print reading and GD&T, Statistical Process Control, Lean Manufacturing,
• Six Sigma, and Gage/fixture design
• Demonstrated expertise in production processing
• Capable of utilizing inspection equipment to verify products
• Demonstrated ability to implement, maintain, analyze and react to various production performance metrics and KPIs
• 7+ years hands on experience in a GMP environment

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Tuition reimbursement
• Vision insurance