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At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

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.

•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

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

• 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

Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.

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. 

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.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package

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.

Salary ranges for U.S (excl. PR) locations (USD):$122,400.00 - $183,600.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Medtronic benefits and compensation plans (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here (http://www.medtronic.com) .

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.

At Medtronic, most positions are posted on our career site for 3-7 days.

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We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.

We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will…

• Build a better future, amplifying your impact on the causes that matter to you and the world

• Grow a career reflective of your passion and abilities

• Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

These commitments set our team apart from the rest:

Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

Better outcomes for our world . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care

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.

For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .

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If you need assistance completing your application please email AskHR@medtronic.com

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