Principal Project Engineer (Medtronic)

Job Title: Principal Project Engineer
Company: Medtronic
Location: Brooklyn Park, MN

Manage development of significant, new and innovative technologies and devices using applied winding, mechanics, and fluid dynamics priniciples. Lead the development of device test methods to characterize performance and demonstrate attainment of requirements of new concept and device designs. Work in conjunction with product development teams to translate new innovations into appropriate conditions for scalability in Phase-Gate Product Development Process. Improve existing in-vitro testing processes, technologies and protocols to meet testing requirements. Results of work will be used for design input and to satisfy internal risk management and external regulatory guidelines.

Position Responsibilities

1. Assume technical expert role in developing new disposable perfusion product concepts and apply technologies to create new product designs. Coordinate efforts of internal and external technical personnel to meet goals. Demonstrate feasibility of concepts from initial idea generation through manufacturing scale up. Investigate options and apply new technologies to create novel design approaches.
2. Develop and implement test techniques to fully investigate the integrity of new perfusion product viability. Identify and develop appropriate test and analysis methods that reasonably represent expected device conditions, to characterize and select concept options. Prepare plans/reports and perform testing of products and associated components.
3. Formalize testing methodologies and approach to address comprehensive reliability analyses of designs.
4. Direct completion of specific verification/validation testing and analyses required that satisfy both regulatory and internal Medtronic requirements.
5. Coordinate with outside consultants and clinicians to ensure testing and analyses required to fully qualify and verify device designs are appropriately representative of expected use conditions.
6. Provide guidance on test lab resources, ensuring that sufficient testing resources are in place to support development project needs.
7. Develop prototype and production scale up manufacturing methods and technologies, coordinating with internal and external resources to meet time, cost and technical goals
8. Provide clear and regular technical direction regarding concept and technology options, assessment criteria, pros and cons of options and recommendations to professional, technical and administrative personnel. Coordinate the preparation and design of high quality presentation materials and prototypes to define alternative design approaches to management, marketing and clinicians. Must be able to confidently present all or any of these concepts to the customer or company management.
9. Prepare or direct the preparation of oral and written reports of current status, progress, and terminal status of total project, as required by the customer, project or department management. Requires the ability to place large and complex programs in proper context and communications skills allowing incumbent to express project status in that light.
10. Maintain technical knowledge current with advancing technology related to winding technology and perfusion disposables products. In order to improve individual overall effectiveness and avoid technical obsolescence, engage in continuing education programs in order to broaden knowledge in selected discipline and to gain knowledge in new fields of engineering, device testing and technical expertise leadership.
11. Characterize any novel materials used in new concepts by determining thermal/mechanical/chemical test methods appropriate to satisfy regulatory agency and Medtronic requirements.
12. Provide counsel and training to more junior professionals or other specialist when their assignments relate to key deliverables.
13. Perform required training and certifications to demonstrate compliance with applicable divisional and corporate policies in accordance with individual training matrix.

Basic Qualifications

- Bachelors in Mechanical or Materials Science Engineering, with at least 10 years of experience.
Foundation in applied fiber winding technology and design of wound fiber devices
- Extensive experience with new product and new concept development, investigation of promising technologies, and forward thinking applied research
- Extensive experience with product concept prototyping, testing and analysis
- Experience with machine design and manufacturing processes
- Experience with instrumentation, applied in testing, analysis and measurement
- Extensive experience demonstrating feasibility of proposals, selecting appropriate judgement criteria and assessing multiple options
- Demonstrated communication skills; present complex technical scenarios to management
- Solid CAD system experience
- Knowledge of risk management analysis techniques including Failure Mode and Effects Analysis (FMEA

Desired/Preferred Qualifications

- MS or PhD in Mechanical or Materials Science Engineering
- GMP, QSR and ISO 9001 experience
- Basic understanding of motion control
- Understanding of plastic part molding and manufacture
- Understanding of low pressure fluid dynamics
- Understanding of blood contacting devices or disposable medical device development and/or manufacturing, including FDA and EU guidelines
- 9-13 years of relevant experience with Bachelors, 7-11 years with Masters, 4-8 years with Doctorate, plus 5 years of experience in the fiber winding industry.
- PC skills (MS Word, Excel, PowerPoint, MS Project, etc.)
- Strong CAD design skills
- Strong oral communication skills
- Strong written technical communication skills
- Demonstrated strong leadership and skills in both interpersonal and group settings
- Negotiation and influencing skills, able to lead vendors, develop statements of work and manage external resources
- Comfortable presenting to groups
- Ability to give work direction to multiple engineers and technicians
- Ability to travel both domestically and internationally

Physical Job Requirements

- Hearing, sight and speaking ability
- Ability to use computers
- Ability to travel
- Sitting, standing 8 hours/day
- Ability to travel both domestically and internationally

How to Apply

Please click here to apply: http://jobs.medtronic.com/job/1245829A9

Source: Mechanical Engineering Jobs at Engineer Jobs.com

This position, Principal Project Engineer (Medtronic), was posted on January 20, 2012. The employer is Medtronic. Since this job has been published, it has been viewed 32 times.