Mechanical Design Engineer - Principal.

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Help bring the next generation of life-changing medical technology to patients worldwide.

The Principal Mechanical Design Engineer for Medtronic CRM RPE will be responsible for technical and mechanical design leadership for market-released implantable cardiac devices.

This role involves collaboration with cross-functional partners such as reliability, regulatory, operations, and sourcing colleagues to evaluate and implement design changes.

Represent the organization as the prime technical contact on contracts and projects.

A Day in the Life :

• Interact with personnel on significant technical matters often requiring coordination between organizations
• Identifies and oversees testing required to obtain necessary data to support field actions, regulatory renewals, submissions and deficiency responses
• Provide critical evaluation of device design when representing design in review of Change Impact Forms (CIF’s)
• Initiates change activity (CA) to modify maintain design documentation (BOM’s, Specs, drawings)
• Supports CAPA’s (Corrective & Preventive Actions) and RPI’s (Released Product Investigations) including possible CAPA ownership
• Provides RPE input to new product development teams
• Assists Regulatory Specialists by providing design & clinical use data and rationale to support worldwide regulatory submissions and certification renewals.
• Supports IQ / OQ / PQ, DOE’s, SPC, Gauge R&R, Sampling methodologies, Data Analysis, Hypothesis Testing, Modeling / Predictive Analyses, Capability Studies (CpK) and Component Qualifications
• Collaborates with reliability and manufacturing personnel to determine and execute appropriate tests / assessments to evaluate supplier, process, material, design, or component changes prior to implementation
• Collaborates with reliability, manufacturing, materials, and R&D to investigate product performance issues / returned product analysis to identify root cause(s) and implement corrective action(s)
• Assists manufacturing sites with lean layout initiatives, interfacility transfers and outsourcing
• Supports cost reduction and continuous improvement projects
• Provides problem solving / trouble shooting support to manufacturing sites and key suppliers to increase yields, maintain process capability, and improve efficiency and cost
• Supports internal and external regulatory compliance audits
• Actively participates in new product development to RPE transfers; ensures completion of all transfer deliverables

Must Have : Minimum Requirements

• Bachelors degree required
• Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience

Nice to Have :

• Proficient knowledge of CRM devices (ICD’s, IPG’s, CRT-D / P, ICM)
• Working level understanding of CRM product implant procedures, clinical use conditions, new indications, competitive product landscape & state of the art industry status
• Proficient knowledge of medical device industry standards, regulations compliance requirements
• Basic knowledge of mechanical processes, materials, processes, PFMEA and DFMEA
• Demonstrates good judgment pertaining to issue escalation and consultation with other SME’s
• Able to work independently and exercise appropriate latitude when addressing abstract, yet to be defined technical issues and problems
• Results focused. Able to deliver consistent, high quality work to meet product performance, compliance, schedule, and budget requirements
• Able to provide solutions to a variety of technical problems of challenging scope and complexity
• Possesses working knowledge of statistical and data analysis tools. SPC, DOE, Gauge R&R, CpK
• Demonstrates clear, factual, and effective oral and written communication with variety of cross functional colleagues, technical peers, and senior-level management
• Able to facilitate cross functional group problem solving, decision making, and small projects; including CAPA’s
• Able to effectively prioritize and work on multiple assignments in parallel while keeping stakeholders updated
• Able to work independently, follow established procedures, and give / receive technical peer reviews of work deliverables for accuracy of technical content
• Bachelor’s Degree in Mechanical or Biomedical Engineering
• 7+ years of Medical Device Industry Experience
• MS in Mechanical or Biomedical Engineering
• Excellent time management skills with ability to manage multiple priorities and deliver on time
• Solid leadership and interpersonal skills including ability to effectively formulate and convey technical and cost / benefit / risk information with peers and senior leaders
• Strong verbal and written communication skills including ability to articulate complex ideas in easy to understand terms
• Working knowledge of Quality System Regulation (QSR 21 CFR 820), EU Medical Device Directive, and ISO (13485 : 2003)
• Knowledge of 6 Sigma (DFSS) principles

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 .

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