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Principal Mechanical Systems Engineer

2 months ago

Kalamazoo, Michigan, United States Comrise Full time

Position Overview

  • Responsible for the design, validation, and market introduction of innovative products.
  • Defines detailed functional requirements for new products; designs, tests, and integrates components to create final designs; assesses overall effectiveness, cost, reliability, and safety of designs.
  • Develops, executes, and evaluates fitness-for-use testing, product specifications, and process validation plans; creates and reviews material specifications and bills of materials.
  • Works collaboratively with internal manufacturing teams, contract manufacturers, designers, and product specialists to enhance designs for manufacturability.
  • Employs CAD (Computer Aided Design) or CAE (Computer Aided Engineering) systems to model new designs and generate comprehensive engineering drawings.
  • This role functions independently, requiring sound judgment in applying professional expertise with minimal supervision.
  • Typically necessitates a university degree or extensive practical knowledge acquired through experience.
  • Requires a solid understanding and application of procedures and concepts within the discipline.
  • Attention to detail is crucial for making evaluative judgments based on factual analysis.

Qualifications


• Preferred experience in the medical device sector. Self-motivation and effective task management are essential.


• Familiarity with PPAP, process validation, and process development; program management experience is advantageous.


• Experience in electro-mechanical projects with embedded software is required.


• This is an individual contributor role requiring approximately 5 years of relevant experience.


• Supplier and vendor management will be a critical aspect of this position; candidates with these skills are preferred.


• Engineers will collaborate closely with external vendors to procure parts and ensure compliance with specifications.


• Emphasis on process validation is necessary; candidates should have experience in evaluating entire manufacturing assembly processes, including pFMEA, risk analysis, and process control plans.


• Proficiency in Production Part Approval is required; candidates should be capable of working with vendors to ensure consistent part delivery.


• Ideally, candidates should possess medical device experience or experience in regulated industries such as pharmaceuticals, automotive, or aerospace.


• We seek team players who are quick learners, problem solvers, and self-motivated individuals who can define tasks based on objectives, identify issues, and propose solutions.


• Experience with pressure leak systems will be a significant advantage.


• Preferred experience in plastics joining and welding.