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