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Senior R/D Engineer – Sustaining

Black Enterprise Magazine

This is a Full-time position in Boulder, CO posted September 9, 2021.

Senior R/D Engineer
– Sustaining
Location:
Boulder, Colorado, United States
Requisition #:
21000H3J
Post Date:
Jul 02, 2021

**Careers that Change Lives**
SUMMARY OF POSITION:

Within the Airways RD sustaining engineering group, the Sr.

sustaining engineers primary responsibility will be to support Airways disposable medical devices currently on the market.

The Sr.

sustaining engineer will research and validate components, materials and applications while sustaining current product designs.

The Sr.

RD Engineer is responsible for the design history files, determining test requirements and coordinating VV testing.

In addition to implementing moderate design changes that either enhance performance or address quality issues, the Sr.

sustaining engineer performs complaint investigations, determines root cause failure modes and provides solutions for these product lines.

ESSENTIAL FUNCTIONS:

+ Provides technical support for existing products by developing solutions for problems complex in nature and/or of relatively high organizational impact with a high level of accountability and authority and relatively minimal supervisory oversight.
+ Serves as a mentor and technical leader for less experienced engineers and technicians within the sustaining engineering group.
+ Works to maintain product performance and quality for existing products by leading and assisting with issues relating to CAPAs, customer complaints and manufacturing processes, such as:
+ Failure investigation and root cause analysis
+ CAPA resolution
+ Regulatory compliance
+ Product Design Verification and Design Validation
+ Design changes
+ Test methods and tooling design
+ Process enhancement and improvement
+ Provides research on raw materials, components and assemblies for MoC compliance (Materials of Concern, RoHS, Prop65, etc).
+ Follows strict adherence to policies and procedures associated with an FDA controlled environment.
+ Generates Engineering Change Orders to support product sustaining efforts.
+ Works with clinicians technical issues and communicates solutions at the appropriate level.
+ Identifies immediate solutions for short term corrections to prevent impact to business goals.
+ Works to integrate product performance activities with new/ derivative product development to improve project delivery time and reduce post release production issues.
+ Leads and manages projects to implement design changes.

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

+ Prepares analysis reports for director(s), project leaders or other personnel.
+ Presents project status to management and teams, as required.
+ Develops and tracks work schedule and assignments.
+ Provides input to departmental planning and resource activities.
+ Other duties as assigned with or without accommodation.

**A Day in the Life**
Responsibilities may include the following and other duties may be assigned.

+ Designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development.
+ Designs studies to investigate specific life science questions within field of expertise.
+ May be involved in product research and development and/or clinical trials.
+ Translates research discoveries into usable and marketable products.

**Must Have: Minimum Requirements**

+ Bachelors degree required
+ Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

**Nice to Have**
Preferred Skills/Qualifications:

+ Demonstrated experience and a proven track record of success in product support evidenced by lowered support costs and by a failure rate reduction
+ Experience with internal and outsourced sustaining development projects
+ Proven ability to partner cross functional organizations to successfully drive the business (relationship building skills is key influencing working through people)
+ Solid working knowledge of quality and regulatory requirements, plus experience dealing with regulatory agencies or outside professional groups (e.g.

FDA, ISO, ANSI, HIMA)
+ Must be a strong communicator, verbal and written, across all levels of the organization as well as cross functionally
+ Must be an extensive multi-tasker, and problem solver with high energy levels and strong organizational abilities.

Must be organized and attentive to details, and must have strategic and tactical thinking.
+ Medical Device and clinical environment experience
+ CAD Solidworks proficiency (3d moldes and 2d drawings)

Skills/Competencies:
Problem solving, priority setting, customer focus and driving for results

Other Skills:
Must communicate effectively in English, both written and verbal

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

+ Partners closely with Global RD Sustaining Engineering leaders
+ Works on moderate to complex engineering tasks and provides weekly updates with their Supervisor.

WORKING CONDITIONS:

+ Normal office conditions and engineering labs
+ Clinical Environment
+ International travel to Design Centers, Manufacturing plants and Contract manufacturing facilities

**About Medtronic**

Together, we can change healthcare worldwide.

At Medtronic, we push the limits of what technology, therapies and services 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 want to accelerate and advance our ability to create meaningful innovations
– but we will only succeed with the right people on our team.

Lets 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.

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.

(ADA-United States of America)
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.