Sr. R&D Mechanical Engineer - Redmond, United States - MicroSurgical Technology
Description
Senior R&D Mechanical Engineer
As Senior R&D Engineer, you will be part of our Ophthalmic instrumentation research and development team focused on delivering the future in Ophthalmic surgeries.
This role will involve a range of responsibilities including but not limited to 3D CAD models and documentation, design analysis, material research, prototype design, build and testing, design of test fixtures and test method development, manufacturing support and interface with the cross functional product development team.
Position is on-site in Redmond, Washington.Responsibilities:
Utilize multidisciplinary engineering knowledge and experience to design and develop new products specific to Ophthalmic surgery.
Plan, schedule and coordinate project tasks and activities.
Effectively communicate with management and cross functional team members.
Conceive and build working prototypes.
Run empirical and experimental analysis utilizing various analytical design tools.
Work with outside consultants, vendors, machinists and the medical community.
Support bench / animal testing and clinical evaluations.
Establish product requirements and specifications.
Develop clinically relevant test models and test methods for design evaluations.
Create and maintain 3D CAD models, assemblies, and prints.
Reviews and provides functional approval for project and quality system documentation.
Ensure compliance with procedural and documentation requirements of FDA, ISO and other regulatory bodies.
Participating in Material Review Boards for discrepant material evaluation, root cause analysis, and corrective actions.
Analyze customer feedback, market trends, and technological advancements to identify areas of improvement for existing products.
Supports in ensuring product and performance specifications are appropriate and accurate.
Collaborate with cross functional teams to propose and implement enhancements, design modifications, or cost optimizations to meet customer needs and stay competitive in the market.
Work closely with cross-functional teams to identify and resolve technical issues related to existing products, i.e. CAPS's or NCR's.Requirements:
BS in Mechanical Engineering with minimum of 7 years of experience in medical device mainly in Research & Development in medical device or other highly regulated industry.
Must be able to communicate effectively, both verbally and in writing.
Proficiency with inspection tools and methods.
Working knowledge of, and experience in applying, FDA Design Controls and international standards (e.g., Design Controls, 820-CFR, ISO14971, ISO10993, IEC60601, GMP, etc.).
Desirable Skills and Experience:
Experience with metal machining, fabrication, and finishing methods.
Knowledge of lean manufacturing processes.
Experience in the practical application of statistics and working knowledge of a statistical analysis package (Minitab).
Company Overview:
Microsurgical Technology is a leading innovator in the field of ophthalmic surgery, with a reputation for delivering high-quality surgical instruments and advanced surgical solutions to improve patient outcomes.
A privately held medical device company founded in 1978 and based in Redmond, WA, MST specializes in the design and manufacturing of precision surgical instruments for ophthalmic surgery.
We are dedicated to providing high-quality products and exceptional customer service, with a focus on improving patient outcomes and advancing the field of ophthalmic surgery.
MST's product portfolio includes a wide range of surgical instruments such as forceps, scissors, hooks, spatulas, and knives, all designed for the delicate and intricate procedures required in microsurgery.
Salary range for this position is $100k-$150k per year which is the general base range for a successful candidate in the State of Washington.
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.
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
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