Careers that Change Lives:
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. Join us to make a lasting impact. We believe that when people from different cultures, genders, and points of view come together, innovation is the result, and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. Help bring the next generation of life-changing medical technology to patients worldwide.

Position being posted in advance of need for future upcoming opportunities

This Senior Mechanical Design Engineer will contribute to the development of new/modified cardiac surgery disposable and capital goods products that meet application, business, customer and regulatory requirements. Based on input from business partners, prepare schedules and proposals for designs that meet all Quality and customer requirements. Collaborate with other Design, Research, Manufacturing and Quality colleagues to ensure designs are capable of being manufactured consistently and cost effectively. Document design in accordance with applicable Product Development Protocol, Quality and Regulatory requirements. Prepare regulatory submission-ready documentation for the FDA and other regulatory bodies. Support multiple projects within the Development group. Provide work direction and training to other engineers and technicians.

A Day in the Life:
•Contribute to design, development, research and support of new/modified cardiac surgery products for medical applications in a regulated environment.
•Create robust design solutions that address broad development problems involving class I, II and III devices and accessories.
•Work with external medical professionals and internal technical colleagues to determine device requirements.
•Support sustaining engineering programs on existing products to ensure sustainable and stable operations of production. Identify areas that require additional investigation.
•Set objectives and milestones for assigned projects to address initially complex problems. Provide project planning and management for multi-functional or cross-business project assignments.
•Develop and maintain product and process specifications working with external medical professionals and internal technical and Marketing colleagues to establish device requirements.
•Participate in the specification and direct completion of specific verification/validation testing and analyses required that satisfy both regulatory and internal Medtronic requirements.
•Performs data analysis (statistical and practical) and develops appropriate action plans based upon such analysis.
•Prepare in-depth analyses and recommend solutions to product design test issues, or product performance issues as a result of product complaints, Manufacturing and/or Quality issues.
•Organize, prepare and present technical information material and current project status in a clear, effective and skillful manner to Management, Marketing and clinicians. Prepare tradeoff studies and implement alternative approaches to mitigate schedule delays. Communicates progress and decisions to associates and functional manager
•Document design solutions and design modifications in accordance with internal Medtronic, industry and regulatory requirements.
•Contribute to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
•Work with external suppliers/vendors to establish engineering requirements, specifications and agreements

Must Have - Required:

BS in Engineering and at least 4 years of Industry experience or an MS in Engineering and at least 2 years of industry experience

Nice to Have:

M.S. in Mechanical Engineering

Knowledge of human anatomy and physiology

Experience with disposable and/or injection molding

Experience with surgical product development, design control and manufacturing

Experience with Design Verification, Design Validation and design control (e.g., Product Development Protocol, Design History Files and Device Master Record)

• Knowledge and experience in engineering mechanics, mechanical design, and structure and properties of materials.

• Proven ability to produce effective solutions to product issues with complex technical requirements

• Proven ability to effectively interface with customers and internal clients

• Experience and knowledge in working in an analytical laboratory setting

Proven, hands on experience with laboratory testing methods, fixture development and fluid flow measurements

• Strong leadership and skills in both interpersonal and group settings

• Ability to work effectively in fast-paced, rapidly changing engineering environment

• Strong oral and written technical communication skills

• Broad knowledge of manufacturing process for medical devices, design control and Quality Systems

• Good Manufacturing Practices (GMP)/Quality System Regulations (QSR)

• Knowledge of FDA, MDD, and CMDR

• Experience with FEA modeling

• Experience with GMP, ISO 13485:2005, and QSR 21 CFR part 820

• Proven experience with CAD software such as SolidWorks and/or Creo

• Computer skills (MS Word, Excel, PowerPoint, MS Project, Minitab, etc.)

• Working knowledge of risk management analysis including Failure Mode and Effects Analysis (FMEA), advanced analytical and statistical techniques and DOE

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)

The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.

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. Learn more about our benefits here .

Medtronic Incentive Plan : This position is eligible for an annual Bonus Program. Learn more about Medtronic Incentive Plan (MIP) here .