Job Title: Sr. Engineer
Location: Irvine, CA
Duration: 18 Months

Job Description;
Summary: The Quality Engineer will collaborate with a cross-functional design team to develop novel cardiovascular device/therapy, providing quality leadership and vision throughout the initial product development cycle up to commercialization, while ensuring compliance to applicable internal and external requirements. In this position, the engineer will work closely with R&D to define strategy, as well as refine and finalize the design per the NPD process. In addition, the engineer will work with the Operations team to help facilitate successful transfer/launching of robust products. This position provides an opportunity to work in a fast paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success.

Responsibilities:

• Collaborate with R&D and Operations teams in Design Engineering, Risk Management, Design Controls, Design Verification, Statistical Techniques, Test Method Development, Process Development, Quality Assurance, and Regulatory Compliance.

• Lead Risk Management process for project in compliance to external standards and corporate policies, ensuring critical to quality features are identified and addressed.

• Create and maintain risk management documentation such as risk management worksheet, FMEAs in alignment with ISO:14971.

• Provide technical input for project plans, timelines, and strategy to support premarket approval of products.

• Partner with R&D engineers to support design verification/validation strategy and testing, including test method development/validation activities.

• Demonstrate strong leadership and collaboration with other project leaders and across the organization.

• Mentor engineers in understanding quality systems and strategies within new product development.

• Support root cause investigations/product evaluations for product failures during clinical use using engineering methods (Six Sigma, DMAIC, etc.).

• Support resolution of manufacturing and compliance issues (CAPA, non-conformances, audit observations, etc.) using problem-solving tools.

• Support Quality Engineering activities to improve customer satisfaction and achieve company quality objectives.

• Ensure compliance with all National/Federal, local, and company regulations, policies, and procedures.

• Train, coach, and guide lower-level employees on complex procedures.

• Oversee Quality support tasks; instruct engineers/technicians on conducting tests; train and provide feedback; may coordinate engineer/technician work.

Skills:

• In-depth knowledge of Design Control, Risk Management, and related standards for medical devices.

• Knowledge of Quality Engineering and Six Sigma concepts with ability to apply to work product.

• Strong technical and analytical engineering skills; able to understand drawings and device design at a practical level.

• Excellent verbal and written communication skills; able to communicate clearly, concisely, yet thoroughly.

• Strong leadership skills and ability to influence change.

• Ability to handle multiple tasks simultaneously.

• Must be accurate in handling detailed information/data.

• Experience in early human use NPD strongly preferred.

• Experience in Design for Manufacturing (DFM) preferred.

• Certified Six Sigma Black Belt / CQE preferred.

• Experience with electronic devices, data transmission/acquisition a plus.

Education/Experience:

• Bachelor's Degree or equivalent in Engineering with 4 years in related industry experience OR

• Master's Degree in Engineering with 3 years in related industry experience

 

About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
 
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
 
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer. 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $56.00/hr.