Senior Mechanical Engineer

2 months ago

Kalamazoo, United States Comrise Full time

Overview

  • Designs, validates and brings new products to market.
  • Specifies precise new product functional requirements; designs, tests and integrates components to produce final designs; and evaluates the design's overall effectiveness, cost, reliability and safety.
  • Designs, develops, executes and evaluates fitness-for-use testing, product specifications and process validation plans; creates and reviews material part specifications and bills of materials.
  • Collaborates with internal manufacturing partners, contract manufacturers, designers and product specialists to optimize designs for manufacturability.
  • Utilizes CAD (Computer Aided Design) or CAE (Computer Aided Engineering) systems to model new designs and produce detailed engineering drawings.
  • This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision.
  • Roles typically require a university degree or an extensive amount of practical knowledge gained through experience.
  • Job requires an understanding and application of procedures and concepts of own discipline.
  • The job requires attention to detail in making evaluative judgements based on the analysis of factual information.


Qualifications

• Preferred Medical Device experience. Self-Motivation and task management is expected

• Experience with PPAP, process validation, process development Program Management experience is an asset.

• Project is electro-mechanical with imbedded software - experience in these types of projects is required.

• It is an individual contributor with ~5 years’ experience.

• Supplier/Vendor Management will be a key function of the job. We want some people with those skill sets.

• The process engineers at company all work very closely with external vendor procuring the parts and ensuring those parts meet our specifications.

• Emphasis Process Validation. We have gotten candidates that had equipment qualification (i.e., ensuring a single piece of equipment is functioning as expected and produces the correct results) but we need people that have experience looking at and entire manufacturing assembly process and validating the whole process. Key word like pFMEA, Risk Analysis, Process Control Plans should help narrow the candidate.

• Production Part Approval. We need someone who is capable of taking a part design and working with the vendor, review their process and define the process that will ensure that the vendor delivers the correct part every time.

• Ideally, we want the candidates to have medical device experience and may consider someone with experience in regulated industries like pharma, automotive and aerospace.

• Want to add that they are a, team player, quick learner, problem solver, self-motivated. We need someone who can be given objectives, then define the task themselves for review, identify problems and propose solutions.

• Any experience working with Pressure Leak systems will be a huge asset

• Plastics Joining Welding experience will be preferred

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