Job Title: Quality Engineer

Job Description

Currently looking for a Quality Engineer to work in the developmental stage of our product: an implantable medical device for cardiac function. Our mission is to design, develop, manufacture, and integrate MEMS (micro-electromechanical sensors) for cardiac applications to assist with long-term, home monitoring for several chronic diseases. The Quality Engineer will actively participate in project team meetings, providing status updates as needed, and will utilize QMS software and processes for product development and data management. Excellent communication skills are essential for effectively sharing engineering direction with our suppliers, customers, and within the organization. The candidate will lead problem-solving activities and root cause analysis, leading to product and process improvement opportunities.

Responsibilities

• Work with cross-functional teams to streamline design documentation for regulatory submissions.
• Prepare quality and regulatory documentation, including design specifications, manufacturing procedures, test methods, and manufacturing drawings.
• Actively collaborate with engineers in equipment assembly and execution of installation and operational qualifications.
• Improve quality and characterization test reports by developing Process Flow Charts, SOPs, Component Specifications, and Work Instructions.
• Perform troubleshooting and root cause analysis.
• Conduct hazard and risk analysis, and prepare necessary documentation, including DFMEA, PFMEA, and Hazard Analysis Documents.
• Develop test protocols and final reports within the cross-functional team, providing guidance on advanced Quality Engineering practices.
• Communicate test results concisely and in a timely manner.
• Authorize DHF requirement documents, verification & validation plans/reports, functional verification protocols, and other risk documentation for multiple design change projects.
• Document each step of the Lifecycle process, including User Requirements Specification (URS), Function Requirements Specification (FRS), System Design Specification (SDS), Traceability Matrix, Validation Plan, and Validation Summary Report.

Essential Skills

• Bachelor's degree in mechanical engineering or related field.
• Hands-on experience with quality implementation and processes in medical devices (or aerospace/defense).
• Experience with corrective action planning.
• Ability to read design prints and understanding of ISO standards.
• Knowledge of Control Plans, PPAP, RIR, DOE, GD&T, failure investigation techniques, statistical quality controls, protocol and report preparation, and non-conforming product controls.

Additional Skills & Qualifications

• Experience with the FDA approval process.
• Working knowledge of ERP and MRP systems for material handling and maintenance of BOMs.

Work Environment

The work environment consists of office space with individual offices available for each employee. Additionally, there is a clean room environment on-site where the product is being manufactured.

Pay and Benefits

The pay range for this position is $40.00 - $55.00/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 Ypsilanti,MI.

Application Deadline

This position is anticipated to close on Apr 25, 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 : $40 - $55