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Senior Advanced Processes Development Engineer, Med Device, R&D
4 months ago
Senior Advanced Processes Development Engineer, Med Device, R&D
BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTION
Our client is a growing medical device company focusing on delivering clinically superior breakthrough solutions that significantly impact a person’s quality of life. They are committed to creating the next generation of innovative healthcare solutions having to do with reducing the use of opioids. The company develops, manufactures, and markets its own products to more than 90 countries worldwide.
The Senior Advanced Process Development Engineer will report to the Senior Manager, Advanced Process Development and will be responsible for the design, development, and commercialization of processes and equipment for all new products in R&D portfolio across all lines of business. They will work with project teams and program managers to create/refine product and process specifications through innovative and robust processing solutions. This position is a key member of a critical R&D group that supports all business units.
DUTIES / EXPECTATIONS OF THIS ROLE
· Provide technical leadership of new product process development through the design and development of manufacturing processes and related fixtures and tooling that are consistent with high process capability and low product costs
· Serve as process expert on any given project to support R&D new product development efforts
· Work with vendors and key external suppliers to develop process specifications and arrange equipment, parts and material purchases
· Create and maintain accurate documentation of tool drawings, design concepts, shop orders, and concepts in accordance with R&D and QA functions
· Implement the transition of new technology to ensure production continues without delay
· Estimate equipment costs and development times as inputs to new product development schedules and budgets
· Estimate staffing requirements, production cycle times and relative costs to provide data for operational decisions
MUST HAVES - QUALIFICATION SUMMARY
· Bachelor's degree in industrial, Mechanical, Manufacturing, Electrical or Chemical Engineering
· 7+ years of experience in variety of technical and/or operational assignments within an operations and/or R&D environment (Automotive, Aerospace, etc. Any highly regulated industry)
· Hands on design experience
· Strong experience using manufacturing analysis tools, including but not limited to Designs of Experiments, Design for Six Sigma, Process Capability studies, etc.
· Experience with authoring and reviewing process validation protocols (IQ/OQ/PQ), execution and data analysis
· Experience performing design transfers of new products from initial concept through launch
· Experience developing and leveraging relationships with external suppliers
· Proven collaboration with cross-functional/multi-disciplinary teams.
· Strong analytical skills and problem-solving skills
· Solid knowledge of engineering principles, scientific analysis, and project management
· Strong communication skills (written and verbal)
· Ability to prioritize multiple projects
· SolidWorks for CAD experience
· Experience with appropriate documentation
NICE-TO-HAVES - QUALIFICATION SUMMARY
- Medical Device Experience.
- Prior experience executing complex electronic Class II or Class III medical devices.
- Master’s degree in engineering.
- Factory automation development and installation: programming, layout and design, build and transfer, vision and inspection systems, vendor management.
- Experience in medical device manufacturing assembly processes including but not limited to polyurethane balloon forming, radiofrequency tipping equipment, pad printing, bonding with different adhesive methodologies (UV, solvent, mechanical), vision systems, leak testing equipment, machining, metal working and delivering RF ablation technologies.
- Knowledge of polymer processing techniques including injection molding and extrusion.
TRAVEL & LOCATION
Onsite in Alpharetta, GA
Light travel requirements to Mexico 15%
START & TERM
Immediate start
6-month contract-to-hire (conversion to perm)
