Sr Mechanical Engineer

Requirements

• BS or above in Mechanical, Biomedical, Electromechanical Engineering, or related field

• 4+ years engineering experience with bachelor’s degree or 2+ years with master’s, in medical devices (Class II/III)

• Working knowledge of Design History File (DHF), design inputs/outputs, and traceability

• Hands-on Design Verification, test method development, and execution

• Proficiency with statistical techniques and tools: Gauge R&R, process capability studies, Minitab

• Ability to synthesize technical inputs and draw defensible conclusions/recommendations

Preferred Skills

• Familiarity with IEC 14708 and ISO/EN 45502 (Active Implantable) standards

• Familiarity with IEC 60601 medical electrical equipment standards, including laser-specific clauses

• Test Method Validation (TMV) planning, protocol authorship, and analysis

• Experience with single-use device and/or active implantable test methods

• Requirements management and change control in regulated PLM/ALM systems

Responsibilities

• Define and maintain design inputs; generate design outputs with proper specifications and tolerances

• Plan and execute Design Verification; develop test methods, perform TMV, analyze data in Minitab, and author reports

• Build and maintain complete DHF artifacts, including risk/trace matrices and verification evidence

• Interpret and apply IEC 14708/45502/60601 requirements to product designs and test strategies

• Perform statistical analyses (Gauge R&R, capability) to qualify fixtures, methods, and processes

• Support design reviews, transfer to manufacturing, and sustaining changes with documented engineering justification

Pay Details: $55.00 to $68.00 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.