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 ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan 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.