Supplier Quality Engineer

Role Overview

This position supports Supplier Quality Engineering activities for new product development, specifically components used in the Aortic Transcatheter Valve Replacement Delivery System.

The engineer will support supplier qualification, component qualification, process validation, and test method validation activities.

The team currently has five engineers and is working toward an early-next-year product launch. The hiring manager is looking for someone who can learn quickly, adapt to the team, and contribute with minimal training.

This is a replacement position, and the previous contractor left the assignment.

2. Top 3 Technical Requirements
- Highest Priority

• Supplier qualification and supplier quality experience.
• Supplier coordination and follow-up.
• Ability to manage qualification activities and supplier deliverables.
• Participation in regular supplier meetings.

2. Process Validation
- Very Important

• Basic understanding or hands-on experience with IQ/OQ/PQ.
• Process validation exposure.
• Understanding validation protocols and documentation.
• Ability to support validation activities.

3. Test Method Development & Validation
- Very Important

• Test Method Validation (TMV) experience.
• Developing and executing inspection methods.
• Understanding test methods and inspection procedures.

3. Additional Technical Skills

• Statistical analysis and data interpretation.
• Minitab and Excel.
• Problem-solving and analytical skills.
• Root Cause Analysis (RCA).
• Manufacturing Quality and Inspection Engineering experience.
• Supplier communication and coordination.

Note:

Minitab is preferred, and Excel knowledge is expected.

4. Candidate Experience & Education

Criteria

Ideal experience

1-2 years

Open with relevant internship/co-op

3-4 years

Consider if comfortable with Level 1

4-5 years

Open, subject to level and compensation fit

First preference

Biomedical Engineering

Second preference

Mechanical Engineering

Acceptable if comfortable with Level 1

PhD

Generally overqualified

Industry preference:
Medical device experience is preferred but not mandatory.

The manager is also open to candidates currently working as technicians who have an engineering degree and relevant quality/validation exposure.

5. Acceptable Candidate Backgrounds

Do not restrict sourcing only to Supplier Quality Engineers.

The hiring manager is open to candidates from:

• Supplier Quality Engineering
• Manufacturing Quality Engineering Quality Engineering
• Inspection Engineering
• Manufacturing Engineering
• Biomedical Engineering graduates with relevant internships
• Quality Technicians with an engineering degree and relevant experience

Important:
Candidates from alternative backgrounds must have at least basic exposure to process validation and test method validation.

6. Day-to-Day Responsibilities

• Manage assigned components and their qualification activities.
• Coordinate directly with suppliers to complete qualification requirements.
• Support supplier qualification and component qualification.
• Develop and execute inspection methods.
• Support process validation and test method validation.
• Perform statistical analysis using Minitab and Excel.
• Attend regular supplier meetings.
• Coordinate with the assigned senior engineer.
• Ensure qualification activities are completed within project timelines.

The team manages approximately 100 components, with each engineer responsible for an assigned group of around 10 components.

7. Interview Focus – What the Hiring Manager Will Evaluate

The hiring manager specifically identified these three technical areas:

• Process Validation – IQ/OQ/PQ.
• Test Method Development and Execution.

Additional evaluation areas:

• Statistical knowledge.
• Problem-solving ability.
• Understanding of inspection methods.

Pay Scale

• Anticipated hourly pay range: $35-40/hr

Benefits

Employees hired into this position are eligible for the following benefits, subject to applicable plan terms and eligibility requirements:

• Health Insurance:
  Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.
• Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
• Paid Time Off (PTO):
  No PTO is provided other than that required by applicable state and local laws.