Full-Time
Quality Engineer
Posted on 5/31/2024
Lexington Medical
51-200 employees
Develops advanced surgical stapling technology
Junior, Mid
Bedford, MA, USA
This position is onsite in Bedford, MA.
- Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or related field
- 2+ years of experience in design quality engineering, in the medical device industry (experience with electrical equipment is a plus)
- Experience developing and implementing processes within quality management systems.
- Experience in new product development and introduction (NPD/NPI), and in design transfer
- Strong working knowledge of US and international medical device regulations and standards, including 21 CFR 820, EU 2017/45 (MRD), ISO 13485, ISO 14971, IEC 60601, and IEC 62366
- Demonstrated knowledge of design controls, process validation, risk management, and change control
- Demonstrated application of systematic problem-solving techniques and defect avoidance methodologies
- Experience participating in material review boards
- Supplier quality experience is a plus
- Strong team orientation and ability to lead in a cross-functional environment
- Drive Design Assurance activities throughout the Product Life Cycle
- Provide expertise in Risk Management, Design Verification and Validation, Statistical Methods and Design Controls
- Define and implement processes within the Quality Management System
- Drive quality system execution to US and international standards, including development of quality and risk management plans
- Drive continuous improvement projects, and proactively identify and implement best-in-class quality engineering practices
- Develop test methods and inspection procedures and implement process control systems to support the development, qualification, and on-going manufacturing of products
- Support supplier quality management, including conducting sub-contractors and component supplier audits
- Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues
Lexington Medical focuses on surgical stapling technology for hospitals and surgical centers, particularly in bariatric and gastrointestinal surgeries. Their advanced stapling systems aim to improve clinical outcomes by closing wounds and connecting tissues more effectively. The company is vertically integrated, controlling product development and manufacturing to ensure high quality, and has achieved FDA clearance for their Powered Stapling System. Lexington Medical's goal is to enhance surgical procedures and provide trusted solutions for surgeons worldwide.
Company Stage
Series B
Total Funding
$6.6M
Headquarters
Billerica, Massachusetts
Founded
2013
Simplify's Take
What believers are saying
- Growing demand for minimally invasive surgeries boosts surgical stapling market.
- Rise of outpatient surgeries offers opportunities in ambulatory surgical centers.
- Global bariatric surgery market growth aligns with Lexington's focus.
What critics are saying
- Increased competition from emerging startups threatens market share.
- Supply chain vulnerabilities could disrupt production of stapling systems.
- Potential patent litigation risks may impact innovation pipeline.
What makes Lexington Medical unique
- Vertically integrated, ensuring high quality and control over product development.
- State-of-the-art manufacturing facility in Massachusetts with latest automation technologies.
- FDA clearance for Powered Stapling System, highlighting commitment to innovation.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Disability Insurance
401(k) Retirement Plan
Paid Vacation
Performance Bonus