Sr Manufacturing Engineer-Contract Manufacturing

Medtronic Inc.
North Haven
Oct 03, 2017
Oct 23, 2017
Employer Type
Direct Employer
Employment Type
Full Time
Help us to excel at everything we make and have a direct impact on patient care and lives.

Does this work inspire you?

As part of Medtronic outsourcing team, the Senior Manufacturing Engineer is responsible for the transfer and support of Medtronic Products and processes to Contract Manufacturing (CM) sites. The Senior Manufacturing Engineer will work as a team member with the Quality, R&D, Sustaining Engineering, Procurement, and Contract Manufacturing Organization to ensure the successful transfer and ongoing production of finished Medical Devices at Contract Manufacturers (CM's). Applicant must demonstrate the ability to deliver quality, innovative, cost-effective and timely solutions in a multiple project environment

What is the work you will be doing?

* Manage technical aspects of product and process transition to contract manufacturing partners.

* Ensure manufacturing processes adequately demonstrate specified process control capabilities.

* Provide technical support and guidance to Contract Manufacturer for engineering issues.

* Conduct, coordinate and aid in formal Process Validations including protocol development and execution.

* Manage all technical aspects of the ECO process into the Contract Manufacturing organization.

* Manage localization activities with Contract Manufacturing and Sustaining Engineering.

* Ensure new processes have adequately demonstrated specified process and test control capabilities, through being the Champion for PFMEA, DFM, DFT, DFSS, CAPA and NCR.

* Specify and procure capital in the support of manufacturing and test processes.

* Candidate must have the ability to work independently and be able to communicate effectively with team members.

* Ability to meet at off hours to support of Contract Manufacturers located across the globe with global time zone differences.

* Work as a liaison with the Contract Manufacturer and COV to ensure design for manufacturing elements are incorporated to improve yield and reduce costs.

* Provide guidance to Contract Manufacturer in designs and evaluates new and existing fixtures and equipment, test methods, specifications, layouts, and standards supporting a Lean manufacturing environment.

* Ensures adherence to product specifications, industry standards, and quality and regulatory procedures and requirements.

* Support process verification and validation testing activities.

* Assist with selection and qualification of new materials and suppliers

In Order To Be Considered For This Position, the Following Basic Qualifications Must Be Evident On Your Resume

Required Education:

* B.S. in Engineering, Manufacturing, or other technical field

Required Years Of Experience:

* A minimum of 5 years of experience working in a regulated environment, medical device manufacturing a plus.

Do you have these experiences or skills?

* Experience working with FDA Quality Systems Regulations and ISO Quality Systems.

* Familiarity with SPC, Experimental Design, and Statistical Sampling Techniques.

* Project management skills.

* Experience with Labview a plus.

* Experience with Agile PLM helpful.

* Process verification and validation knowledge.

* Lean manufacturing/Six Sigma concepts and understanding

* International travel required. (Approximately 25%)

* Experience with managing projects

* Experience dealing with suppliers

Organizational Relationships/Scope:

* This position is an individual contributor position with project leadership responsibility and will be located in North Haven, Connecticut.

* The position reports to the Contract Manufacturing Engineering Manager Boulder, Colorado.

About Medtronic:

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements:

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.

EEO Statement:

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.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here:


The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.