Verification and Validation RD Engineer; Senior Level

Manufacturing Engineer

100% onsite - 100 Results Way, Marlborough MA 01752

What You'll Do

• Establish equipment requirements by working closely with product design team, suppliers and the multi-functional project team.
• Align the equipment specifications to reliability and quality requirements within the framework of new products development or management of legacy products.
• Apply analytical and quantitative problem-solving using methods including but not limited to Root Cause Analysis and Design of Experiments.
• Define Manufacturing Process Flow, Master Validation Plan for the overall Manufacturing Process as well as Qualification Strategy for individual equipment.
• Own the DMR for NPI and lead preparation of protocols, test execution and test report for qualification documents including Factory Acceptance Test (FAT), Supplier Acceptance Test (SAT), Installation Qualification (IQ), Process Characterization (DOE), Operational Qualification (OQ), and Performance Qualification (PQ), Process FMEA, Gage R&R, Process Capability (Cpk), Statistical Process Control (SPC), Purchase specifications and Quality Control Specifications.
• Publish standard methodologies around Process Development; coach and mentor team members on Lessons Learned.
• Support Manufacturing Engineering Team and Market Support Team for complex issue solving for legacy products (e.g. production issues, customer complaints, customer requests).
• Work in a multidisciplinary Research and Development team, in close interaction with the Production, Supply Chain, Sourcing and Quality departments, as well as suppliers.

Who You Are

• Bachelor's degree required. Master's degree or equivalent in related scientific or engineering fields (mechanics, micro-mechanics, engineering) preferred.
• 5+ years' experience in designing, developing, transferring and maintaining manufacturing technologies and processes associated with regulated industry (medical device, class II and/or class III).
• 5+ years' experience in performing qualification and validation of manufacturing process (IQ, DOE, OQ, PQ, Process FMEA).
• Founded knowledge and practical experience of relevant regulations (ISO
  13485, FDA 21 CFR Part 820), specifically for the US and European market product submission.
• Strong organizational and interpersonal skills.
• Familiar with the following manufacturing processes: machining, injection molding, compression molding, tube extrusion, thermoforming, heat staking, heat sealing, ultrasonic welding, laser welding, snap-fitting, UV gluing, solvent bonding, automated assembling, labeling, packaging or other related experience.
• Self-starter, hands-on, creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues.