Manufacturing Engineer, Medical Device Assembly & Packaging
Overview
Own end-of-line manufacturing processes for medical device OEMs at Quality Tech Services, a Cretex Medical company. You will develop and improve procedures, tools, and fixtures while monitoring equipment performance to ensure production goals are met. Collaborate with Quality teams to integrate new products, root-cause nonconformities, and drive corrective actions. This role focuses on process optimization, statistical process control, and design for manufacturability in a regulated ISO13485 environment. Stand out by implementing process improvements and supporting next-generation programs.
What You'll Do10
- 1Develop and maintain manufacturing procedures, documentation, tools, fixtures, and programs for existing products.
- 2Monitor equipment performance and correct process parameters that cause nonconforming products or low yields.
- 3Collaborate with Quality to integrate new products or processes into production.
- 4Identify root causes of nonconformities and implement corrective actions to prevent recurrence.
- 5Initiate technical activities for new or improved products, focusing on design for manufacturability.
- 6Analyze and solve problems from basic engineering principles to advanced challenges using innovative approaches.
- 7Develop and implement process improvements with supervisory guidance.
- 8Maintain and approve device routers, bills of materials, and manufacturing procedures.
- 9Design and coordinate fabrication of process fixturing and gauging.
- 10Map and analyze processes, assess efficiency, and implement complex projects.
Requirements11
- 1Bachelor's Degree in Mechanical, Industrial, or other Engineering Science.
- 2Basic understanding of 3D CAD software such as ProE, Unigraphics, or Solidworks.
- 3Microsoft Office proficiency in Outlook, Word, Excel, PowerPoint, and Publisher.
- 4Excellent communication and influencing skills.
- 5High level of energy, personal accountability, and integrity.
- 6Detail oriented with accurate record-keeping and information organization.
- 7Clear and effective verbal and written communication skills.
- 8Ability to prioritize and multitask in a team environment.
- 9Desirable: Experience in ISO13485 or GMP environment.
- 10Desirable: Manufacturing process design, validation, and equipment/fixture design.
- 11Desirable: Lean manufacturing and statistical analysis, manufacturing automation.
Salary Insight
$68 - $102k per year
Location
Required Skills
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