Job Title: Sr. Design Quality Engineer (Hardware)

Job Description

The Sr. Design Quality Engineer will work closely with internal departments to efficiently deliver safe and effective medical device designs for manufacturing, in accordance with company policies and procedures. This role represents Quality Assurance for hardware design, development, and sustaining engineering. The engineer will support project teams to ensure new and existing products meet customer, corporate, and regulatory guidelines, and collaborate with Design and Manufacturing Engineering to improve processes.

Responsibilities

• Ensure new design projects and design change activities comply with medical device regulations, standards, and internal procedures.
• Participate in design reviews to document and ensure the design meets customer requirements.
• Assist in qualifying molds, fixtures, tooling, and equipment.
• Draft, review, and perform hardware design verification and validation test plans, protocols, and reports.
• Identify testing and analysis required to ensure conformance to product specifications.
• Manage risk management files, including risk management plans, risk analysis, FMEA, FTA, and risk management reports.
• Support manufacturing and operations by performing root cause analysis of product non-conformances found in manufacturing.
• Perform and support process validations.
• Identify, drive, and implement process improvements.
• Work with contract manufacturers to maintain product quality and resolve any non-conformances.
• Support hardware scalability and continuous improvement projects.
• Initiate, review, and approve document change orders (DCOs).
• Drive standard gap assessment activities.
• Support ongoing regulatory submission activities and product approval processes.
• Participate in the implementation and continuous improvement of the Quality Management System.
• Other duties as assigned.

Essential Skills

• Quality assurance
• Medical device quality engineering
• Design control
• ISO 13485
• NCR
• Hardware design
• Verification
• FPGA
• VHDL

Additional Skills & Qualifications

• Bachelor of Science degree in Electrical Engineering required. Master’s Degree preferred.
• 5 years of hands-on experience with hardware design and development in the medical device industry.
• Design experience with FPGAs using VHDL or Verilog.

Work Environment

The current team consists of two people, including the new hire and one other engineer. The team is expected to grow to about five people and will focus on the next generation of generators.

Pay and Benefits

The pay range for this position is $75.00 - $75.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Santa Clara,CA.

Application Deadline

This position is anticipated to close on Feb 28, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $75