Principal R-D Engineer

Employer
Medtronic Inc.
Location
North Haven
Salary
Competitive
Posted
Jan 13, 2018
Closes
Feb 10, 2018
Role
Research
Industry
Computer
Employer Type
Direct Employer
Employment Type
Permanent
Hours
Full Time
PRINCIPAL RESEARCH AND DEVELOPMENT ENGINEER

Careers that Change Lives

Help streamline and speed our time to market and build quality in at every step. You will be a member of the new product development team that supports the design and development of innovative, new products within the Surgical Innovation business. You can apply advanced technical concepts to complex problems from concept generation through early phase development.

SURGICAL INNOVATIONS sets the standard for Minimally Invasive Surgery (MIS) by creating innovative surgical products and services that focus on obesity and diseases and conditions of the gastrointestinal tract, lung, abdominal wall, pelvic region, and the head and neck.

Impact patient outcomes. Come for a job, stay for a career.

A Day in the Life

A Principal Research & Development Engineer will be responsible for managing portfolio strategy for a subset of the Hernia & Hemostat business. Work involves identifying & exploring new product development opportunities that drive sustainable, profitable growth in existing and adjacent market spaces. This would include a primary focus on Meshes, BioSurgery, Mechanical Fixation devices, and related and evolving technologies. Responsible for a subset of the portfolio of hernia & Hemostats device projects, including ownership of activities contracted to the R&D sites and third parties.

Responsibilities Include:

* Complete product and procedural opportunity assessments consistent with divisional strategies

* Identify new opportunities, technologies and products that address unmet needs, expand served markets or enter new ones

* Assess customer and procedural needs, generate product concepts, assess feasibility, strategic fit and financial metrics

* Present opportunities to Sr. Management, gain alignment on funding and deliverables

* Create Project Charters with identified cross functional partners; ensure compliance to stated project goals.

* Work with R&D partners to establish product specifications, scope, budget and timeline details to meet business objectives

* Establish, execute, and report on funded product development deliverables, taking project from concept through commercialization either through internal contracting with R&D centers or external partners

* Conduct needs assessments; create concepts and product testing via models and prototypes.

* Present and participate in portfolio strategy discussions to set and achieve strategic goals

* Develop a strong understanding competitive strategy, technology and IP landscape, consult with management and cross functional partners in Competitive Counter Positioning, tactics and strategy.

* Performs preclinical and clinical assessments

* Recommends and implements productivity gains.

* Adheres to safety policy procedures

ADDITIONAL FUNCTIONS:

* Conducts project management tasks & documentation with design controls and risk analysis in accordance with established SOPs.

* Incorporates required regulatory standards (FDA, ISO) in developmental and/or sustaining engineering projects including written protocols, test methods, assembly processes and the Design History File.

* Prepares and maintains research findings, summaries, logs and notes and develops statistical results or research.

* Prepares reports, presentations and spreadsheets of an analytical and interpretative nature to be presented to peers, executives, surgeons, customers, and at society meetings.

* Remains abreast of laboratory analytical applications to include changes/enhancements in research studies, laboratory technology, and research standards.

* Prepares research findings and supporting data for peer journal publication, oral presentation, or other dissemination and archiving.

* Guides the successful completion of major programs and may function in a key functional leadership role.

* Contributes inventions, new designs and techniques regarded as advances in the medical and technical/scientific community.

* Assumes supervisory responsibility as needed.

* Can interpret and effectively communicate technical findings to a broad audience.

* Anticipates and identifies problems of a wide range including those requiring research and or analysis.

* Collaborates with peers to manage the development of appropriate testing to verify product meets internal and external customer requirements.

* Failure to achieve results or erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives and result in a considerable expenditure of resources.

* Exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long-term perspective, for desired results.

* Solutions are imaginative, thorough, practical and consistent with organization objectives. Solutions may create or extend precedent.

* Works on complex technical projects and provides highly innovative solutions that require the regular use of ingenuity and creativity.

* Represents the organization in providing imaginative, thorough, practical solutions to difficult technical issues associated with specific projects that are consistent with the organization objectives.

* Trains and mentor others in specialized area.

* Adheres to safety policy and procedures.

Must Have: Minimum Qualifications

* Bachelor's degree required

* Bachelor's plus a minimum of 8 years relevant experience; or Master's plus a minimum of 5 years relevant experience; or PhD plus 3 years relevant experience. Education in Engineering, Scientific or Technical discipline required.

* Innovation management

* In-depth understanding of medical device industry and competitor products. In-depth knowledge of other related disciplines.

* In-depth understanding of clinical and regulatory pathways, IP and internal processes.

* Must keep abreast of new science and technological developments and exploit them to continuously improve functional area capabilities.

* Applies extensive technical expertise to develop innovative approaches to work.

* Develops advanced technological ideas and guides their development into a final product. Anticipate and identify level of clinical evidence required for product.

* Complete understanding of anatomy relative to surgical procedures for specific products.

* Excellent communication skills both oral and written. Effectively communicate and works cooperatively with others as part of a team.

* In depth knowledge and application of investigative research and analysis.

* Thorough knowledge of laboratory instrumentation and computer software skills utilizing research-based applications.

* Ability to compile and organize technical data using Excel, Word, or Access.

* Working knowledge of biological laboratory safety precautions and protocols for safe handling and the disposal of hazardous agents, re-agents, chemicals and materials.

* Working knowledge of applicable FDA and ISO standards.

* Definition of technical solutions for product developments.

* In-depth knowledge and experience in transferring designs to manufacturing.

* In-depth knowledge of mechanical design and development of complex delivery systems for medical devices.

* Thorough understanding of engineering practices, product safety and root cause analysis.

* Knowledge of GMP for tooling, molding, design and process methods.

* Working knowledge of rapid prototyping, material selection, and product design and process specs.

* Working knowledge of Design for Six Sigma, Failure Mode Effects Analysis, Statistical Analysis methods, and Design of Experiments.

* Knowledge and experience with medical device materials and biocompatibility testing.

* Working knowledge of preclinical study designs, execution and interpretation of results.

* Medical device product development experience strongly preferred.

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

Regular cross functional contact at all levels. Significant collaboration with Strategy and Portfolio, Global Marketing and Site R&D teams. May participate in a cross GBU programs, and manage external contract work. Frequent contact with customers and external service organizations.

WORKING CONDITIONS:

* Work usually performed in an office setting.

* Significant time engaging customers in OR theatre and hospital or lab settings.

* Up to 25% domestic and or international travel may be required.

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. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

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.
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