Support new product development for surgical instruments by leading risk management, design verification, and quality engineering activities to ensure compliance and product excellence.

Requirements:

Bachelor’s degree in Engineering or related field

Experience in Risk Management (Hazard Analysis, DFMEA, UFMEA)

Experience with Design Verification authoring and execution

Experience with change control, CAPA, and ISO 13485 requirements

Understanding of mechanical and electro-mechanical design principles

Experience with process validation and complaint analysis

Preferred Skills:

Proficiency with statistical analysis tools (Minitab or equivalent)

Experience with risk management tools and methodologies

Knowledge of validation and qualification activities including CTQ matrix, process flows, control plans, and capability analyses

Familiarity with design and manufacturing processes for medical devices

ASQ Certified Quality Engineer (CQE) certification

Knowledge of regulatory and quality standards: ISO 13485, ISO 14971, ISO 60601, FDA Quality System Regulations

Understanding of software and hardware interface in medical devices

Responsibilities:

Participate in product development cycle through review of project documentation and product risk assessments

Facilitate development of risk management tools including risk management plans, reports, hazard identification, and complaint analysis

Define, review, and execute design verification and validation testing requirements

Plan and support process validation activities including measurement system analyses and process capability analyses

Collect, analyze, and interpret statistical data, providing reports and recommendations to management

Collaborate with cross-functional teams to ensure sustainable manufacturing and continuous improvement initiatives

Pay: 40-54

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

Pay Details: $40.00 to $54.00 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.