Resonetics · 3 hours ago
Senior Manufacturing Engineer
Bethel, CT
Full-time
Onsite
Senior Level
$88K/yr - $120K/yr
5+ years expResonetics is a global leader in advanced engineering and micro manufacturing in the medical device industry. The Senior Manufacturing Engineer will lead advanced manufacturing process development and CNC programming initiatives, supporting new product introduction and continuous improvement for medical devices.
Life ScienceManufacturingMedical Device
No H1B
Responsibilities
Program new CNC jobs and optimize/ modify existing CNC programs (Milling, Multi-Axis, and Wire EDM)
Design and conceptualize fixtures, tooling, and work-holding solutions for repeatable, high-efficiency production
Troubleshoot CNC programs, machining processes, equipment issues, and work-holding constraints
Apply high-efficiency machining techniques and support machining of exotic/high-temperature alloys
Provide runtime, cost, and work-holding estimates for new product quotations
Develop clear work instructions, setup sheets, and visual aids; train operators on proper CNC setup and operation
Act as Manufacturing Engineering representative on NPI core teams, supporting product launches from early concept through production transfer
Manage development and build schedules for new and existing medical device programs, interfacing directly with customers and Business Development
Design and develop scalable manufacturing processes, tooling, and fixtures that ensure product quality, operator safety, and production efficiency
Transfer new processes and product lines from multi-site R&D or prototyping teams to production, ensuring readiness and sustainability
Provide hands-on line support: troubleshooting equipment, implementing process improvements, addressing operator inquiries, and optimizing workflows
Create and maintain manufacturing documentation in accordance with ISO 13485 and internal QMS practices
Lead process validation activities including IQ/OQ/PQ, TMV studies, equipment commissioning, and preventive maintenance documentation
Ensure compliance with customer specifications, FDA requirements, OSHA standards, and applicable regulatory guidelines
Prepare detailed engineering reports and effectively communicate results to internal stakeholders and customers
Identify and implement improvements that reduce cycle time, lead time, and cost while enhancing yield and product quality
Drive utilization of Lean, Six Sigma, A3, 5-Why, DMAIC, and other structured problem-solving methodologies
Lead cross-functional efforts with Engineering, Operations, Quality, Logistics, HR, and external partners to resolve technical challenges
Act as a change agent, promoting best practices, disciplined engineering rigor, and data-driven decision making across manufacturing teams
Qualification
Required
5+ years of experience in precision CNC manufacturing
Experience in Medical device or regulated environment is preferred
Strong background in CNC Milling and Multi-Axis machining including programming, setup, optimization, and troubleshooting
Proven CAD/CAM experience (SolidWorks, Mastercam, Esprit, or equivalent)
Experience machining exotic alloys and performing high-efficiency machining
Demonstrated experience designing and developing manufacturing processes, tooling, and fixtures
Proficiency in NPI/PDP processes and transferring products from prototype to production
Strong analytical skills including DOE, regression, ANOVA, and process capability analysis
Strong written communication skills, with ability to generate procedures, reports, and validation protocols
Experience working within ISO-9001/13485 or similar regulated environment
Ability to lead cross-functional teams and manage multiple projects simultaneously in a fast-paced environment
Excellent interpersonal skills; able to train operators and collaborate effectively across functions
BS or MS in Mechanical, Manufacturing, Biomedical, or related Engineering discipline
Preferred
MS degree in Engineering or related field
Experience in interventional medical device assembly, packaging, or sterilization
Experience with Wire EDM, small-hole EDM, and turning systems
Lean Six Sigma certification or formal training
PMP certification or demonstrated project management experience
Experience serving as a multi-discipline core team lead for NPI medical devices
Company
Resonetics
Resonetics provides laser micromachining contract manufacturing solutions and systems for the life sciences and other high precision.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
$1.12BKey Investors
The Carlyle GroupRegatta Medical
2021-12-03Private Equity· $1.12B
2018-02-01Private Equity
2014-10-22Acquired
Leadership Team
Todd Trapp
Chief Financial Officer
D
David Rezac
Global Vice President, AGILE Product Development
Recent News
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