Project Engineer 8/9/2016
Saint Paul, MN
JOB DESCRIPTIONAPPLY Our client is looking for a Project Engineer to lead development teams working on disposable and reusable surgical products.
1. Manage Projects.
2. Follow QualitySystem/Design Control Processes.
3. Apply knowledge of materials and processes.
4. Design/Re-design/Document product and fixtures using CAD (AutoCAD, SolidWorks)
5. Professionally represent the company with customers and vendors.
6. Perform other tasks as requested.
1. Manage Projects:
* Manage projects and develop product concepts for FDA and CE Class I, II and III products including disposable and reusable surgical products.
* Lead 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 QualitySystemrequirements 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.
2. Follow QualitySystems and Design Control Processes:
* Prepare and maintain documentation in support of ISO 13485 and FDA 820 qualitysystems including design control; such as Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), Technical Construction Files (TCF), Work Instructions (WI), Manufacturing Procedures (MP), Bill of Materials (BOM), Etc.
* Write test plans, protocols and reports for Design Verification, Design Validation, Process Validation, Packaging Validations, 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 (DCRs).
* Investigate product complaints; Participate in Corrective Actions/Preventative Action process.
* Facilitate identification of root cause for quality and clinical issues that arise for current products.
3. Apply knowledge of materials and processes:
* 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 processes.
* Establish in process inspection methods and processes.
* Draft manufacturing process validation plans, protocols and reports.
4. Design/Re-design/document product and fixtures using CAD (AutoCAD, SolidWorks):
* Ability to design/re-design/document products and fixtures using Solid Works and/or AutoCAD.
* Translate user inputs into design/product specifications.
* Create novel design solutions to meet users unmet or under met needs.
* Apply knowledge of ASME Y14.5M Drawing Practices for creating and maintaining engineering drawings; using appropriate tolerances (GD 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 company's proprietary intellectual property, business practices, trade secrets and potential physician or hospital derived patient or procedural information (HIPAA).
a. 3+ years' work experience in an ISO 13485/FDA medical device design/manufacturing environment required.
b. Project management, such as product development, process development, continuation development required.
c. 3+ years' experience (intermediate level) using CAD including 2D drafting (AutoCAD) and 3D modeling (SolidWorks) preferred.
d. 3+ years' experience producing engineering drawings from CAD models including dimensioning, use of tolerances and inspection features per ANSI/ASME Y14.5 AND ISO 8015 preferred.
e. Technical writing of test plans, protocols and reports utilizing statistical methods required.
f. Experience performing product design qualifications, verification and process validation inspections and tests required.
g. Experience with constructing simple fixtures for mechanical testing and manufacturing processes preferred.
h. Experience with supplier qualifications via first article inspections including: development of first article inspection protocols; interpret data and drive action plan to reconcile non-conformance; draft first article inspection reports; validating supplier's capability to make parts to specifications; determine inspection and acceptance criteria required.
i. Experience with non-conforming material and Material Review Board (MRB) procedures preferred.
j. Proven record of finding solutions to design or production challenges through research, networking, experimentation, and brainstorm teams, etc. preferred.
a. Either a 4 year technical degree (BS/ME, BS/IT, BS/Mfg. Engineering, etc.) with 3 years of product design and development or project management work experience; or a 2 year technical degree in product design, mechanical design, or manufacturing engineering with 5 years medical device related work experience preferred.
b. Design knowledge and/or processing experience with materials and processes such as: Stainless steel, titanium, nitinol, thermal plastics, and silicones including molding, machining, forging, heat treating, planting, welding, passivation and electro polishing required.
c. Proven math skills to include algebra, geometry, and trigonometry required.
d. Ability to apply statistical method and tools including: determine sample size; establish confidence and reliability levels necessary with sound justification; develop capability and/or process validation plans with statistically sound sample sizes and analysis preferred.
e. Required software skills to include Microsoft Office, AutoCAD and Solid Works. Software skills with Minitab and MS Project preferred.
f. Qualitysystems knowledge includes familiarity with FDA qualitysystems including cGMP and design controls. Knowledge of ISO 13485 requirements along with experience with FMEAs, DOEs and risk assessment methods is preferred.
g. Print reading ability to include tolerance stack up assessment, press fit sizing, threads, GD&T required.
h. Part inspection experience using micrometers, calipers, optical comparator and other general hand instruments required.
Blu-Alliance assists in the hiring of top level talent in the Medical Device, Life Science, High-Tech, and Healthcare Management industries. We hire for contract, direct hire, and contract to direct hire opportunities!