MS&T Engineer II

Company: STAAR Surgical
Location: Aliso Viejo
Posted on: May 27, 2023

Job Description:

MAIN JOB RESPONSIBILITIES / COMPETENCIES
Support manufacturing in technical areas including:
1. Develop and execute experiments, tests, and protocols to evaluate and validate critical raw materials, with an ability to analyze results, make recommendations, and develop reports.
2. Investigate complex raw material compliance issues (e.g., CAPA, non-conformances, audit observations), with an ability to make recommendations and develop reports.
3. Develop and execute experiments, tests, and protocols to evaluate and validate process improvements, with an ability to analyze results, make recommendations, and develop reports.
4. Provide assistance in troubleshooting/resolving day-to-day raw material and production issues.
5. Support the qualification of production equipment, fixtures, and tooling.
6. Collaborate with cross-functional team to meet deliverables and timelines.
7. Continuously improve existing STAAR's supplier's processes, manufacturability, and sustainability.
8. Collaborate with the Chief Chemist and manufacturing team to support improvements and maintain constant raw materials availability for the manufacturing process.
9. Other duties as assigned.

REQUIREMENTS

EDUCATION & TRAINING
--- Bachelor's degree in science or engineering field (Chemical Engineering, Chemistry, or similar degrees are preferred).
--- Lean/Six Sigma or similar training a plus.

EXPERIENCE
--- At least 3 years of relevant experience in medical device or other regulated industry.
--- Familiar with process engineering (process development, experimental design, statistical analysis, and process optimization).
--- Cleanroom experience a plus.
--- Experience with animal tissue a plus.
--- Water Purification Systems experience a plus.
--- Chemical assessment and characterization experience a plus.

SKILLS
--- Exposure to medical device compliance standards such as ISO13485, FDA guidelines, cGMP, EHS guidelines, Supplier Quality and Process Validation preferred
--- Excellent at prioritization and multitasking
--- Excellent communications skills to senior management levels as well as technical, quality and manufacturing operator levels, both verbal and written.
--- Outstanding interpersonal skills including conflict and relationship management
--- Good knowledge of MS Office Suite programs (e.g. Excel and PowerPoint)

Pay range is $85k to $105k - Final compensation will depend on experience.

STAAR Surgical is an Equal Opportunity/Affirmative Action employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status, or any other characteristic protected by law.

Keywords: STAAR Surgical, Aliso Viejo , MS&T Engineer II, Engineering , Aliso Viejo, California