Qualifications:

• Mechanical engineering or biomedical engineering background required
• Minimum 2 years of experience
• BS in Mechanical Engineering or Biomedical Engineering strongly preferred
• Experience in biomedical product development within a regulated product environment required
• Experience in research and development stage medical device or pharmaceutical projects including verification and validation activities preferred

Responsibilities:

• Lead engineering test effort to guide product development of drug delivery system
• Work closely with the science and medical device design project teams to make evidence based design decisions
• Independently build and conduct test plans to answer key development questions
• Closely follow test SOPs to obtain consistent test results
• Analyze data to draw substantiated conclusions and clearly communicate results
• Troubleshoot electromechanical systems and equipment as problems arise
• Organize test records and documentation
• Develop quality management system (QMS) documentation within the context of good manufacturing practices (GMPs) and suitability for eventual submission to FDA or other regulatory bodies
• Maintain lab supplies and equipment needed for test effort

Skills:
Familiarity with regulatory standards, such as FDA regulations for medical devices.
Excellent problem-solving skills and attention to detail.
Effective communication skills to collaborate with cross-functional teams.

Notes: This job description is intended to provide a general overview of the position. Other duties may be assigned as needed to support the goals of the organization. This position may evolve into a full-time position depending upon performance and employee interest.

Job Type: Part-time

Salary: $28.00 – $35.00 per hour

Expected hours: 20 – 30 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Schedule:

• Day shift

Ability to Commute:

• Kingston, WA 98346 (Required)

Work Location: Hybrid remote in Kingston, WA 98346