LanceSoft is hiring: Sr Manufacturing Engineer - Exempt in Billerica

JOB DESCRIPTIONTop 3 technical skills that are required for the role:Evaluate, develop, validate and implement manufacturing processes and process improvements for Medical devices or regulated industriesProblem solving, root cause investigation, experience with CAPAunderstanding of lean manufacturing and six sigma toolsEducation Required:Bachelor of Science Degree in Mechanical Engineering, Packaging Science, or similar discipline.Years' Experience Required:Minimum of 5 years in medical device or pharmaceutical industry in Manufacturing Engineering, Packaging or Quality Engineering.Requires practical knowledge and demonstrated competence within manufacturing engineering, process development, packaging engineering typically obtained through advanced education combined with experience.Knowledge and working experience of Lean manufacturing and six sigma practicesKnowledge and general understanding of ISO 11607 part 2, ASTM and ISTA package test methods is preferredWill the contractor be working 40 hours a week? Any overtime for this role? 40 hours per week, no overtimeDoes this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? On-site 4-5 days per week (Billerica/Bedford MA)What is your timeline for scheduling interviews? ASAPWhat product line will this person support? Cardiac Ablations Solutions, cardiac mapping and navigation systems and catheter-based cardiac ablation technologiesThe Manufacturing Engineer will lead and support various process improvement and remediation activities. Activities to include but not limited to the following.Fixture design, procurement, installation, validationProcess map, process development, time studies, line layoutsLabeling system set-up, system updates, documentation updatesProcess validation IQ/OQ/PQAuthor, update, and execute engineering Protocols and closing ReportsDocumentation PLM system updates (BOM, SOP, visual aids, drawings, Work instructions)Conduct and support Root Cause Analysis, Measurement System Analysis, gemba walks, update PFMEA and control plansSupport and process Non-Conforming Material Reports (NCMRs), CAPAs and Audit FindingsWeekly reports, updates, administrative task (as needed)Conduct testing (as needed)Manufacturing and engineering support (as needed)Minimum RequirementsBachelor of Science Degree in Mechanical Engineering, Packaging Science, or similar discipline.Minimum of 5 years in medical device or pharmaceutical industry in Manufacturing Engineering, Packaging or Quality Engineering.Requires practical knowledge and demonstrated competence within manufacturing engineering, process development, packaging engineering typically obtained through advanced education combined with experience.Knowledge and working experience of Lean manufacturing and six sigma practicesKnowledge and general understanding of ISO 11607 part 2, ASTM and ISTA package test methods is preferredWork location:On-site: Bedford, MA and Billerica MA