Senior Manufacturing Engineer, NPD
Our global medical device client is looking for manufacturing engineer (NPD) who would be responsible for the development of manufacturing methods to produce and bring to market advanced technology products (including capital equipment, re-usable and single use medical devices). This a 6 month contract- remote.Responsibilities
- Work on and/or lead new product development or sustaining engineering teams designing, developing, implementing, maintaining or improving manufacturing, assembly, test, and packaging processes for continuous manufacturing methods and technologies. Influence product and manufacturing design changes for improved COGs and manufacturing scalability. Participate in the design and development towards clinical use and commercialization. Ensures cost, quality and headcount expectations are met, and project maintains timeline. (30%)
- Develop techniques for manufacturing, assembly and test, including assembly and test fixtures. Validate processes, evaluate failure data from the field to find root cause and implement sound engineering solutions. Contribute to the intellectual property position of the company via invention and patent applications (25%)
- Develop acceptable documentation for the manufacturing process or product (including but not limited to: Lab notebooks, DOEs, Routers, Work Instructions, Test methods, Drawings, Specifications, PFMEAs, Control Plans, Master Validation Plans, Measurement System Analysis Plans, Protocols and Reports, Validation Protocols and Reports in a timely and manner. (20%)
- Participate and/or manage prototype builds, engineering builds, verification and validation builds, and provide technical data and /or report outs.
- Assist and lead product and process transfers to manufacturing facilities. Work with the operations staff to ensure products under development are optimally manufacturable and resolve manufacturing issues (10%)
- Help identify strategic vendors and assess technical capabilities for developing long term material supply chains to support Launch activities (5%)
- Ensure compliance with quality systems, all relevant internal procedures an d policies and all applicable regulations. (5%)
- Train peers, provide direction to Engineering Technician activities especially those related to prototype creation and product testing as required. (5%)
BS (MS preferred) in Engineering, Science, or related fieldLicenses/ Certifications
Solidworks, GD&T certification, PE license a plusExperience: 5+ relevant years
- Act as ME lead for NPD projects. Develop methods for manufacturing complex components and assemblies. Design, develop, construct and implement tools, fixtures (includes test fixtures, as req'd.) and gages. Implement automation as appropriate for site. Consistently leads Process Validation efforts. Lead efforts to submit Capital Expenditure Requests for new equipment, tooling, gaging.
- Develop, Improve, and maintain all manufacturing documentation for highly complex processes per compliance in assigned areas
- Lead engineering studies and process validation efforts. Write and submit protocols for execution.
- Work with the quality group lead investigations, identify and implement corrective and preventative actions, provide the necessary engineering inputs to appropriately disposition material
- Execute Design Transfer process deliverables and gate reviews for larger scale / complex projects with minimal supervision. Partner with lead floor support engineer in design transfer deliverables. Capture voice of the factory in DFM reviews and design transfer meetings. Support factory level execution. Get input from floor support team to identify and select new equipment to support NPD production.
- Analyse highly complex technical manufacturing problems in the manufacture or purchase of raw material through finished goods, provides innovative solutions and implements those solutions to maintain efficient flow of product.
- Demonstrated knowledge and understanding of complex GD&T, measurement system analysis and tolerance stack analysis. Able to read, interpret and update drawings for complex detailed parts and assemblies. Able to choose and perform the appropriate method of tolerance stack analysis for complex assemblies.
- Advanced understanding of project scheduling and reporting tools inclusive of risk registers, ability to create project plans for large complex projects requiring significant cross-functional team effort. Able to lead projects with limited supervision.
- Ability to collect data and utilize Minitab to run a capability analysis. Understand Cp, Cpk, normal distribution. Ability to determine study sample sizes through hypothesis testing. Write process characterization/engineering study protocols. Determine if data is statistically valid and write reports. Perform trouble shooting for non-normal data and/or data that does not meet criteria. Recommend process parameter changes as required for repeat testing.
- Able to perform Root Cause Analysis, VSM, DFM analysis and complete Design Transfer/Risk Management deliverables. Basic understanding of VAVE, MSA, Lean manufacturing principles, and 6 Sigma.
- Advanced understanding of MS Office applications: Word, Excel, PowerPoint, MS Project, Visio. Thorough understanding of S&N applications including Sharepoint, SAP, Matrix, Agile as appropriate by site.
- Working knowledge of standard machine shop equipment.
- Ability to create and/or update design files and drawings in Solidworks.