Manufacturing Engineer

Manufacturing Engineer for medical device production to design and optimize manufacturing processes, layouts, tooling, and controls in a regulated environment.

Requirements

• BS in Engineering and 3+ years of manufacturing engineering experience

• Demonstrated problem-solving using DMAIC methodology

• Medical device manufacturing experience (cGMP/ISO 13485 environment)

• Proficiency with Document Control Systems and ERP (e.g., SAP, Oracle, NetSuite)

• Knowledge of Lean manufacturing principles and waste reduction techniques

• Competency with statistical analysis, process capability, and DOE fundamentals

• CAD proficiency for tooling/fixture concepts and line layout updates

• Experience generating work instructions, routings, and PFMEAs

• Ability to author and execute validation protocols (IQ/OQ/PQ)

Preferred Skills

• Green Belt certification or equivalent DMAIC project portfolio

• Experience with automation integration, vision systems, or PLC/HMI interfaces

• Familiarity with PPAP, APQP, and supplier process change control

• Knowledge of MSA, gauge R&R, and calibration systems

• Advanced Excel for data analysis and dashboards; Minitab or similar statistical software

Responsibilities

• Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, machining, and material handling

• Develop efficient machine and cell arrangements to maximize throughput, safety, and quality

• Define sequences of operations and specify procedures for tooling and equipment fabrication impacting product performance

• Adapt machine and equipment designs to factory constraints and evolving production conditions

• Incorporate in-process inspection and test requirements into production plans and control plans

• Monitor machinery, equipment, and tool performance; investigate issues and implement corrective and preventive actions to ensure product quality

• Lead Lean/DMAIC projects to reduce scrap, cycle time, and changeover; document results and sustain gains

• Maintain and release controlled documentation (BOMs, routings, work instructions) within the Document Control System and ERP

• Support validation activities (IQ/OQ/PQ), ECN implementation, and continuous improvement of line layouts and standard work

Pay Details: $33.00 to $40.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.