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Sr. Design Quality Engineer
4 months ago
Company Overview
MicroSurgical Technology (MST) is a highly profitable ophthalmic surgical solutions company headquartered in Redmond, Washington. MST is part of Halma PLC, a UK-based conglomerate with over $2.3B in annual sales.
Our products are surgeon-designed and meticulously crafted to instill confidence and assurance in Cataract and Glaucoma procedures. Every MST product meets the highest standards and is designed with extraordinary care and attention to all elements of the product, including packaging, look and feel, and ease of adoption into practice. Our 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.
Founded in 1976, MST’s passion is creating exceptional surgical devices and instruments used to restore or improve sight for patients all over the world. And it is our relentless pursuit of addressing our customers’ needs that creates a profound customer preference. Together, we create a place where we are successful, motivated by our mission and inspire each other. This is where you can do your best work
Senior Design Quality Engineer
The Senior Design Quality Engineer will be instrumental in driving the quality assurance aspects of product design and development, from concept through to market release. This role requires a seasoned professional with a deep understanding of medical device regulations, standards, and quality management systems (QMS). A successful candidate will collaborate closely with cross-functional teams to ensure that design controls, risk management, and validation activities are effectively executed and documented in accordance with regulatory requirements.
Key Responsibilities:
Lead the quality engineering activities in product development projects, ensuring compliance with ISO 13485, FDA QSR, and other applicable regulations and standards.
Facilitate the application of design controls, including design and development planning, input, output, review, verification, validation, and transfer activities.
Ensure that development activities follow design control requirements (demonstrated via Traceability Matrix), product is tested per applicable standards, ER/GSPR are met per the MDD/MDR, and product is properly transferred to manufacturing per applicable specifications.
Champion risk management activities according to ISO 14971, ensuring risks are identified, evaluated, and mitigated throughout the product lifecycle.
Collaborate with R&D, regulatory affairs, manufacturing, and other departments to ensure quality and regulatory requirements are integrated into the product development process.
Author, review and/or approve technical documentation, including, but not limited to, design specifications, DFMEA, PFMEA, verification & validation protocols/reports, product labeling, equipment qualifications, and design changes, ensuring they meet regulatory and quality requirements.
Lead complex root cause analysis and problem-solving activities related to product design and development.
Support continuous improvement initiatives by identifying opportunities to enhance the QMS, particularly in areas related to design and development.
Participate in internal and external audits and lead the resolution of any findings related to product design and development.
Share technical expertise with others and develop/mentor other engineers.
Serve as a subject matter expert on Quality-related matters (e.g. risk management, human factors, statistical analysis) in their application to design controls, and provide guidance and training to others, as necessary.
Provide expert interpretation of current and emerging regulations, standards and guidance impacting the design and development process.
Reports on Quality Objective performance related to design quality during Management Review and other quality metric focused meetings.
Assist in the preparation of submissions for regulatory agencies.
Performs other duties assigned as needed.
Requirements:
Bachelor’s degree in Engineering or a related field.
Minimum of 5 years of experience in the medical device industry, with a strong focus on quality engineering and regulatory compliance.
In-depth knowledge of FDA QSR, ISO 13485, ISO 14971, ISO 62366, ISO 15223, and other relevant standards and regulations.
Expertise in statistical analysis techniques and tools.
Excellent communication and interpersonal skills, with the ability to work effectively in a cross-functional team environment.
Proven experience in leading quality engineering activities in medical device product development, including design controls and risk management.
Strong analytical, problem-solving, and project management skills.
Desirable Skills and Experience:
ASQ Certification (CQE, CRE, or similar) is highly desirable.
Salary range for this position is $115-145k 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
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