Engineer II - Supplier Quality Engineer

AFR Affera Inc
Billerica, Massachusetts, US
Full-time

Locations : Billerica, Massachusetts, United States of America

Time Type : Full time

Posted on : Posted 4 Days Ago

Job Requisition ID : R8206

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

Medtronic is seeking an Engineer II to join the Supplier Quality Engineering team at our Affera manufacturing site in Billerica, MA.

The Supplier Quality Engineer II will be responsible for ensuring the quality and compliance of products and materials sourced from suppliers.

This role involves collaboration with cross-functional teams to develop and implement supplier quality standards and drive continuous improvement initiatives.

Primary Responsibilities

  • Assist in the development and implementation of supplier quality management strategies.
  • Conduct supplier audits and assessments to ensure compliance with Medtronic’s quality standards and regulatory requirements.
  • Support the investigation and resolution of supplier-related quality issues and non-conformances.
  • Collaborate with suppliers to implement corrective and preventive actions (CAPA).
  • Participate in supplier selection and qualification processes.
  • Support continuous improvement initiatives related to supplier quality.

Must Have : Minimum Requirements

  • Bachelor’s degree in engineering or related field
  • Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience

Nice to Have : Preferred Requirements

  • Experience in Printed Circuit Board manufacturing and cable manufacturing (EE preferred) for the Capital / Hardware SQE position.
  • Experience with catheter manufacturing, polymer (extrusion, injection molding), metal precision processing, and adhesives for the Catheter / Disposable SQE position.
  • Medical device manufacturing industry experience, preferably ISO 13485.
  • Hands-on experience with SAP, Trackwise, Agile change management.
  • Ability to manage tasks and projects under tight deadlines with a sense of urgency.
  • Knowledge of quality systems, standards, and regulatory requirements (e.g., ISO 13485, FDA regulations).
  • Strong analytical and problem-solving skills.
  • Effective communication and interpersonal skills.
  • Ability to work collaboratively in a team environment.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles : While performing the duties of this job, the employee is regularly required to be independently mobile.

The employee is also required to interact with a computer, and communicate with peers and co-workers.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package

Scroll down to find an indepth overview of this job, and what is expected of candidates Make an application by clicking on the Apply button.

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.

We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD) : $75,200.00 - $112,800.00. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California.

The offered rate complies with federal and local regulations and may vary based on factors such as experience.

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission to alleviate pain, restore health, and extend life unites a global team of 90,000+ passionate people.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and / or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.

In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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5 hours ago
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