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Resonetics · 9 hours ago

Senior Manufacturing Engineer

Blaine, MN

Full-time

Onsite

Mid, Senior Level

$88K/yr - $120K/yr

6+ years exp

Resonetics is a global leader in advanced engineering and micro manufacturing in the medical device industry. The Senior Manufacturing Engineer will manage production development for medical devices, focusing on process development and continuous improvement while supporting cross-functional teams.

Life ScienceManufacturingMedical Device

No H1B

Responsibilities

Management of new and existing medical device programs. Responsibilities include maintaining development/ build schedules, customer technical interface, and working with Resonetics Business

Development Managers and other Resonetics sites for coordinated production

Design and develop manufacturing processes, tooling, and fixtures that result in sufficient capacity to meet customer demand while also promoting product quality, process efficiency, and operator safety

Provide production line support including, but not limited to, implementing process improvements, troubleshooting equipment, training, and addressing operator inquiries. Generate and modify manufacturing process documentation and assure that documentation follow established policies and procedures per Resonetics established Quality Management System

Drive utilization of process improvement techniques to solve technical problems and make scale-appropriate equipment and process recommendations

Prepare engineering reports and communicate results to both internal (corporate) & external parties (customer)

Drive process validation and documentation (IQ/OQ/PQ, TMV's, Manufacturing Processes, Equipment Commissioning, Preventive Maintenance, etc.)

Qualification

Biomedical EngineeringMedical Device ManufacturingNPIPDPStatistical AnalysisSolidWorksLean Six SigmaISO 13485Project ManagementProblem-solvingCommunication SkillsLeadership SkillsWriting Skills

Required

(BS or MS) in Biomedical/Mechanical Engineering or relevant experience

6+ years of experience in a medical device manufacturing environment designing and manufacturing Class 2 or 3 finished medical devices

Proficient in NPI and PDP and establishing of practices. Demonstrated work ethic and understanding of deadline management

Demonstrated experience solving advanced technical problems using good engineering rigor and problem-solving discipline. Strong analytical skills with the ability to process operational or technical data and translate the output into a business result or opportunity

Strong statistical analysis skills (process capability, equivalence studies, regression, ANOVA, DOE)

Proficient in SolidWorks (or equivalent) for tooling/fixture design. Well versed in GD&T and print generation

Training and/or experience in formal problem-solving techniques (A3, 6-Sigma, 5 Why's, DMAIC, etc.)

Excellent writing skills, able to write detailed reports, comprehensive manufacturing procedures and validation reports/protocols

Ability to drive task clarity in a fast-paced environment with cross-functional stakeholders

Demonstrate project management, planning, and leadership skills

Strong communication skills, comfortable with leading and providing project status updates at the team, customer, and leaderships levels