Quality Engineer II at Medtronic in North Haven, Connecticut

Job Description:

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
The Quality Engineer II serves as a representative of the OU AST Quality that focuses on the stapling product families. The quality engineer will assist in the implementation and maintenance of the quality systems, including the Risk Management Files and Periodic reviews under the Released Product Engineering. The Quality engineer also provides support to the sites that manufactures the released products by being part of their quality and design improvement strategies.
POSITION RESPONSIBILITIES MAY INCLUDE THE FOLLOWING AND OTHER DUTIES MAY BE ASSIGNED:

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.


• Collaborates with engineering and manufacturing functions to ensure quality standards 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; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.


• Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.


• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.


• Develop and maintain Risk Management Documentation which includes FMEAs, QIAs, RACs, IIAs, PHOs and FCAs.

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 on tasks associated with maintaining the Risk Management files, Risk Assessment activities and Change Order for released products - while adhering to policies, using specialized knowledge and skills.

DIFFERENTIATING FACTORS:

• Autonomy: 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.


• Organizational Impact: 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.


• Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
  May have practical knowledge of project management.

MUST HAVE: MINIMUM REQUIREMENTS:

EDUCATION REQUIRED:

• Bachelor's Degree

• 3+ years of Quality Engineering experience with a Bachelors Degree


• 2+ years of Quality Engineering experience with a Masters Degree

• Risk Management experience


• Product Complaint handling


• Quality assurance systems and activities, including MSAs, SPC, Quality Plans, Control Plans, and FMEAs

• Electronics and PCBA experience (design and manufacturing)


• IPC 610 Certification


• Green Belt / DRM certification

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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
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):$76,000.00 - $114,000.00

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, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Medtronic benefits and compensation plans

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.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here .

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.

At Medtronic, most positions are posted on our career site for 3-7 days.