Inginaire - Engineering Staffing

Project Engineer

St Paul, MN
Contact For Rate
Oct 18, 2017
Oct 26, 2017
Job Type
Employment Status
Full Time
Inginaire is looking for a Project Engineer for our client, a dedicated company which provides to the highest quality products and services to the medical community, located in St. Paul, MN.
  • Manage projects and develop product concepts for FDA and CE Class I, II, and III products.
  • Lean matrix structured project teams.
  • Develop project plans, schedules, quotes, and budget estimates: utilize Microsoft Project to create Gantt charts or network diagrams.
  • Drive results to meet milestones.
  • Take ownership of project deliverables to meet FDA and ISO Quality System requirements and customer expectations.
  • Lead team to develop solutions for new and existing products using brainstorming techniques, House of Quality or other methods.
  • Author and coordinate Risk Management activities (FMEA).
  • Collaborate with Sales and Marketing to develop customer/design inputs.
  • Prepare and maintain documentation in support of ISO13485 and FDA820 quality systems including design control; such as Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), Technical Construction Files (TCF), Bill of Materials (BOM), etc.
  • Write test plans, protocols and reports for Design Verification, Design Validation, Process Validations, Packaging Validation, etc.
  • Apply appropriate statistical methodologies to establish sound sample sizes and test variables.
  • Lead team and document results of design risk assessment including use of FMEA techniques.
  • Author and process Document Change Requests (DCR's).
  • Investigate product complaints; Participate in Corrective Actions/Preventative Action Process.
  • Facilitate identification of root cause for quality and clinical uses that arise for current products.
  • Possess knowledge of materials and processes related to stainless steels, titanium, nitinol, silicones, thermal plastics,
  • and other medical device related materials and processes.
  • Evaluate biocompatibility and bio-burden requirements for new and existing products; coordinate testing with outside laboratories.
  • Develop and document manufacturing and inspection process.
  • Establish in process inspection methods and processes.
  • Draft manufacturing process validation plans, protocols and reports.
  • Ability to design/document products and fixtures using SolidWorks and/or AutoCAD.
  • Translate user inputs into design/product specifications.
  • Create novel design solutions to meet users unmet or under met needs.
  • Apply knowledge to ASME Y14.5M Drawing Practices for creating and maintaining engineering drawings; using appropriate tolerances (GD&T) taking into account design needs and manufacturing process capabilities.
  • Establish appropriate Inspection Features on drawings and review with manufacturing partners.
  • Develop packing, cleaning, and sterilization processes for products.
  • Coordinate internal and external resources to translate CAD models to prototypes using SLA, SLS or machined models.
  • Occasional (20%) overnight travel may be needed for visiting vendors, supporting medical society meetings and for educational programs; must be capable of international travel.
  • Must be comfortable meeting with industry professionals such as customers, vendors and physicians for the development and support of products.
  • Must be comfortable viewing and discussing explicit medical procedures that may involve humans or animals for research studies.
  • Must adhere to terms of Confidentiality to protect companies proprietary intellectual property, business practices, trade secrets and potential physician or hospital derived patient or procedural information (HIPAA).

  • Either 4 year technical degree with 3 years of product design and development/ project management work experience; or 2 year technical degree with 5 years of medical device related work experience.
  • Design knowledge and/or processing experience with materials and processes such as stainless steel, titanium, nitinol, thermal plastics and silicones.
  • Proven math skills; algebra, geometry and trigonometry is required.
  • Ability to apply statistical method and tools including: determine sample size, develop capability and/or process validation plans with statistically sound sample sizes and analysis preferred.
  • Advanced skills with Microsoft Office, AutoCAD, and SolidWorks required. Minitab and MS Project preferred.
  • Quality Systems knowledge- FDA Quality Systems including GMP and Design Controls. Knowledge of
  • ISO13485.
  • Experience with FMEAs, DOEs, and Risk Assessment methods preferred.
  • Experience using micrometers, calipers, optical comparators, and other hand tools.
  • Project Management experience required

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