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Quality Engineer II; Stapling Product Portfolio

Job in North Haven, New Haven County, Connecticut, 06473, USA
Listing for: Medtronic plc
Full Time position
Listed on 2026-03-05
Job specializations:
  • Engineering
    Quality Engineering, Biomedical Engineer
Salary/Wage Range or Industry Benchmark: 80000 - 100000 USD Yearly USD 80000.00 100000.00 YEAR
Job Description & How to Apply Below
Position: Quality Engineer II (Stapling Product Portfolio)
We anticipate the application window for this opening will close on - 11 Mar 2026

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.#
** A Day in the Life
** At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

The Surgical Operating Unit (OU) at Medtronic is dedicated to advancing minimally invasive therapies that help improve patient outcomes and transform surgical care. The OU develops innovative technologies across surgical energy, stapling, advanced instrumentation, and robotics, enabling surgeons to operate with greater precision, efficiency, and confidence. By combining deep clinical insight, engineering excellence, and a strong focus on customer and patient needs, the Surgical OU plays a critical role in Medtronic’s mission to alleviate pain, restore health, and extend life.

Medtronic is seeking a
** Quality Engineer II
** to support the
** Core Surgical Innovations (CSI) Stapling product portfolio
** within the Medical Surgical Operating Unit. This role plays a critical part in ensuring the quality, safety, and reliability of released medical devices across their full lifecycle—from design and manufacturing through distribution and product obsolescence.

The Quality Engineer II will work on complex, parallel initiatives that have a direct and immediate impact on product quality, patient safety, and business performance. The role requires strong technical judgment, critical thinking, and collaboration with cross‐functional partners to support continuous improvement, product and process changes, and the resolution of quality issues.
*
* Key Responsibilities:

*** Develops, modifies, applies, and maintains quality standards and protocols for processing materials into partially finished or finished medical device products.
* Supports and risk assessments associated with design changes, released products, and quality events.
* Reviews, approves, and maintains technical documentation related to engineering and design changes, including risk management files and quality records.
* Performs
** Design Failure Mode and Effects Analysis (DFMEA)
** and supports other risk management and technical documentation activities.
* Collaborates with engineering, manufacturing, and cross‐functional teams to ensure appropriate quality standards and controls are in place.
* Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
* Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests.
* Performs statistical and technical analysis to evaluate nonconforming materials or products and supports root cause investigations.
* Ensures corrective and preventive actions meet acceptable reliability and quality standards and that all documentation complies with applicable requirements.
* Supports investigations and assessments related to potential product quality issues in the released product portfolio.
* Contributes to continuous improvement initiatives, including product and process changes driven by market and business needs.
* May specialize in areas such as design quality, incoming materials, production control, product evaluation and reliability, inventory control, or research and development as they relate to product or process quality.
** Minimum Requirements (Must Have!)**
* -Bachelor’s degree in Engineering or a related technical discipline, plus 2 years of relevant quality, engineering, or regulated industry experience, OR
* Masters degree with 0-2 years relevant experience.
*
* Preferred Qualifications:

*** Experience in the medical device industry or another highly regulated environment.
*…
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