Sr. Manufacturing Engineer

Sr. Manufacturing Engineer

On-site in Redmond, WA

Microsurgical Technology (MST) is a manufacturer of medical devices used in ophthalmic surgery. MST's passion is creating exceptional surgical devices and instruments used to restore or improve sight for patients all over the world. We equip surgeons with the most innovative tools, enabling them to achieve the best possible outcomes for patients. We constantly evolve to meet the distinct clinical needs of ophthalmic surgeons through our dedicated partnership with surgeon-designers, bringing innovation to ophthalmology.

MST products meet the highest standards of quality and are designed to evoke confidence during surgery. We devote extraordinary attention to even the finest elements of our products—not only in function but also in the customer experience. Our products are considered industry best-in-class, and all manufacturing is performed in our Redmond, Washington facility.

Role Overview:

We are seeking a motivated and experienced Sr. Manufacturing Engineer with experience in medical device manufacturing.

Responsibilities:

• Design new and revise existing tools and fixtures for assembly, test, and inspection
• Create test protocols for qualifying new products and assemblies
• Develop and document IQ, OQ, PQ and maintenance protocols for new equipment and fixtures
• Develop and implement automation/semi-automation equipment and fixtures
• Participate in Material Review Board to evaluate and disposition discrepant material, conduct failure root cause analysis, develop rework and repair methods, identify and document corrective and preventative action
• Create engineering design and process change orders with required documentation, technical justification/change effects analysis, and impact to operations
• Create, document, and conduct training and certifications for fixture/equipment operation, and critical methods
• Revise existing product designs for improvement or new line extensions
• Develop test equipment and methods for mechanical, electrical, hydraulic, and pneumatic devices and systems
• Develop and maintain production assembly, test, and inspection procedures through product life cycle
• Develop verification and validation protocols for equipment and processes, including validation of cleaning, packaging, and sterilization
• Develop automated data collection and reporting methods
• Lead production process quality improvement
• Determine training and certification requirements for assemblers and technicians for production processes and equipment
• Provide product failure analysis support for customer complaints and returns
• Workflow design, yield improvement, waste reduction, time and motion efficiency studies
• Create and maintain Product and Process FMECA through product life

Requirements:

• BSME with 3-5+ years of experience in medical device manufacturing
• Certified SolidWorks Associate or 3+ years of equivalent experience
• Microsoft Office applications, Excel power user
• Proficiency with inspection tools and methods
• Solid understanding of design change requirements and processes in FDA regulated manufacturing environment
• Ability to perform Gage R & R Analysis for equipment qualifications
• Ability to use Design of Experiments methods to support process improvement

Desirable Skills & Experience:

• Experience developing and implementing automation highly desired
• Experience with metal machining and fabrication and finishing methods and equipment
• Swiss watch or jewelry manufacturing industry with insights into small tools, equipment, techniques
• Experience with color anodizing, electropolishing, chemical etching, laser etching
• Clean room, aqueous cleaning, and sterilization qualification and monitoring
• Lean manufacturing process implementation or support
• Mechanical specification using GD&T
• Quality analysis using Minitab

Salary range is $90k-$135k per year which is the general base range for a successful candidate in the State of Washington. The successful candidate’s actual pay will be based on various factors such as skills, qualifications and experience.

This role is also eligible for a competitive benefits package that includes medical, dental, vision, life, and disability insurance; 401K retirement plan; flexible spending and health savings account; paid holidays; paid time off; parental leave; employee assistance program and other company benefits.

MicroSurgical Technology Inc. is an equal opportunity employer and does not discriminate based on gender, sex, age, race and color, religion, marital status, national origin, disability, sexual orientation, gender identity or expressions, veteran status, or any other category that is protected by applicable law.

Please note that only qualified candidates will be contacted for further consideration.

NO RECRUITERS OR AGENCIES PLEASE

Job Type: Full-time

Pay: $90,000.00 - $135,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Vision insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus opportunities

Application Question(s):

• Are you legally authorized to work in the U.S. for any employer?
• Will you now or in the future require sponsorship for employment visa status?

Education:

• Bachelor's (Required)

Work Location: In person