Sr. Manufacturing Engineer I

MAIN JOB RESPONSIBILITIES / COMPETENCIES

1. Researches, develops and implements improvements to existing and new processes and manufacturing systems to improve quality, productivity, and reduce costs

2. Assists in the research, development and implementation of processes and manufacturing systems to significantly improve productivity, product quality, and reduce operating costs for ICL products

3. Leads and / or assists in the transfer and implementation of processes at and between STAAR’s manufacturing facilities

4. Provides project management associated with new process / product development and the successful transfer into manufacturing

5. Assesses processes for their relevance, and assesses the adequacy of methods, equipment, and instruments

6. Applies statistical and analytical methods such as SPC, Gage R&R, and DOE

7. Establishes test methods, makes observations and takes measurements directly, interprets data from experiments and writes technical reports

8. Develops manufacturing documentation and controls

9. Develops and qualifies new processes, tooling, and equipment (URS, FS, IQ, OQ, PQ, PV)

10. Supports Design Control activities as required

11. Other duties as assigned

REQUIREMENTS

EDUCATION & TRAINING

• Bachelor’s Degree in Manufacturing, Mechanical Engineering, or equivalent, and demonstrated operational experience
• Must possess a high level knowledge of medical device manufacturing equipment; and the use and implementation of associated manufacturing support equipment.

EXPERIENCE

• 5+ years of manufacturing engineering experience preferred.
• 5+ years’ experience in the manufacturing of Class III medical devices desired
• Working knowledge of applicable regulations and standards (i.e. FDA 21 CFR 820 and ISO 13485).
• Significant knowledge of contact and non-contact precision measurement equipment.
• Experience in process improvement methodologies (such as TQM, Lean Manufacturing, and Six Sigma).
• Experience in the utilization of SPC, Gage R&R and DOE methodologies

SKILLS

• Proficient in SolidWorks or other CAD application desirable
• Microsoft Office Word (Power Point, Access, Visio, etc.)
• Proficient in Excel, Minitab, or other statistical software applications
• Familiar with Enterprise Resource Planning (ERP) Systems
• Must have sufficient verbal and written skills to communicate effectively with all levels
• Must possess strong leadership skills, with the ability to coach and motivate.
• Must possess strong analytical and problem-solving skills in an ISO and FDA regulated medical device manufacturing environment
• Comprehensive understanding of SPC, Gage R&R and DOE methodologies

Pay range : $110k - $140k Final compensation / salary will be 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