You will join an advanced team of mechanical, electrical and software engineers responsible for developing Company’s next generation products and newest technologies in the rapidly advancing Gynecological Women’s Health market.
Impact patient outcomes. Come for a job, stay for a career
The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.
Surgical Innovations set the standard for Minimally Invasive Surgery (MIS) by creating innovative surgical products and services that focus on obesity and diseases and conditions of the gastrointestinal tract, lung, abdominal wall, pelvic region, and the head and neck.
Gynecological Women’s Health group is committed to increasing patient access, improving affordability, and expanding less invasive options for women around the world. We will become the leader in GYN by collaborating with the healthcare community, partnering in surgeon and patient education, driving product innovation and standardizing care in MIS and less invasive therapies. We aspire to become the most trusted women’s health company globally.
A day in the life
A Senior Design Quality Engineer in the Woburn, MA office is expected to collaborate and communicate effectively with our cross functional teams and uphold Tenet 3 of the Company mission: To strive without reserve for the greatest possible reliability and quality in our products; to be the unsurpassed standard of comparison and to be recognized as a company of dedication, honesty, integrity, and service.
Provide Quality Engineering support to ensure the successful development of Company GYN products and ongoing operational support. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Actively learn, and apply knowledge of Quality Systems, Design Controls, Risk Management, Statistics and Design for Reliability to positively influence development efforts, quality systems and processes, and ongoing contract manufacturing support as needed.
Ensure products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, customer requirements, and product specifications.
Apply statistical techniques to determine sample size for testing, to analyze data, to determine process capability, to complete Measurement Systems Analyses, etc. (i.e. T-test, Tolerance Analysis, Bayes Success Run/Weibel analysis, Capability Analysis, Design of Experiments/ANOVA)
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.
Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
Innovation and Complexity:
Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
Communication and Influence:
Communicates with senior internal and external customers and vendors.
Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.
Leadership and Talent Management:
May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.
Excellent opportunity to join a global company, lots of room for growth! Apply today! We are eager and still hiring.
Required Knowledge and Experience:
Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
- Bachelor of Science Degree in Biomedical, Mechanical, Electrical, Software, or other related fields
- 4 years of experience in Medical Devices
Nice to have:
- A Master’s Degree in Biomedical, Mechanical, Electrical, Software, or other related engineering field and/or 2 years of experience in Medical Devices
- Applied understanding of industry standards and regulations including, but not limited to: ISO 13485, 21CFR820, European Medical Device Directives (MDD), European Medical Device Regulations (MDR), ISO 14971, IEC 60601 series, IEC 62366-1, IEC 62304.
- Experience with any of the following software suites: Matlab, Minitab, SAS
- Experience applying Risk Management tools (Hazard Analysis, Risk Analysis, FMEA’s, Fault Tree Analysis, Use Error Analysis, etc.)
- Experience applying root cause analysis tools (Fishbone charts, 5 Why’s, DMAIC, etc.)
- Experience writing or guiding product requirements development*
- Experience with gynecological medical devices is a plus, not a requirement