Sr Process Engineer

Senior Test Method Development Engineer responsible for leading test method design, validation, and conditioned testing for novel medical devices within a regulated quality system environment.

Job Requirements

• Bachelor’s degree with 9–13 years of experience, or Master’s degree with 7–11 years of experience, or PhD with 4–8 years of experience in engineering or related scientific discipline.

• Strong understanding of test method development processes for medical devices and sub-assemblies.

• In-depth knowledge of sterilization and aging protocols for medical devices.

• Demonstrated experience working within medical device quality systems to accelerate project delivery.

• Hands-on experience with test method process methodologies.

• Experience leading test method development for conditioned testing (e.g., post-sterilization, post-aging) on novel medical devices.

• Familiarity with regulatory and quality requirements for medical devices (e.g., FDA, ISO 13485, ISO 14971).

Preferred Skills

• Experience supporting design verification and validation activities for Class II or Class III medical devices.

• Experience with statistical methods for test method validation (e.g., Gage R&R, capability studies).

• Background in packaging, shelf-life, or product performance testing under simulated use conditions.

• Experience preparing documentation to support regulatory submissions and audits.

• Experience using electronic quality management systems and laboratory data systems.

Job Responsibilities

• Lead test method development for conditioned testing on novel medical devices and sub-assemblies.

• Define test strategies, protocols, and acceptance criteria for performance, sterilization, and aging studies.

• Execute and/or oversee test method validation and verification activities, including data analysis and reporting.

• Apply medical device quality system requirements to ensure compliance throughout test method lifecycle.

• Collaborate with R&D, quality, and manufacturing teams to ensure test methods align with design inputs and risk management.

• Document all test methods, protocols, reports, and related records in accordance with internal procedures and regulatory standards.

• Identify opportunities to improve test method robustness, efficiency, and throughput and implement process enhancements.

Pay: 55-60

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: $55.00 to $60.00 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

Military connected talent encouraged to apply

To read our Candidate Privacy Information Statement, which explains how we will use your information, please

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.