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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

Medtronic is a 75-year global healthcare technology leader guided by a Mission to alleviate pain, restore health, and extend life — delivering life-transforming technologies across 70+ health conditions in cardiovascular, neuroscience, and surgical care.

Today, our 95,000 employees, including 13,500 engineers and scientists, work across 150+ countries, helping treat more than 75 million patients each year. Innovation at Medtronic is disciplined and well-resourced, with $2.7B USD invested annually in R&D, 2,700+ patents, and 174 active clinical trials, all grounded in a deep commitment to quality, ethics, and putting patients first. As our business grows and we expand our operations in Malaysia, we’re looking for individuals excited to join a team, one where purpose meets potential to build careers that change lives.

Responsibilities:

• Support the sustaining manufacturing line to a high scale production. You will support processes as required to provide daily operations support to the manufacturing floor including inputs to monitoring and control to maintain robust processes.

• This role will interact with different areas in the organization including quality, R&D, Regulatory, Operations, Marketing, Supply Management etc.

• Provide support to the manufacturing processes ensuring output. Support day-to-day activities as manufacturing needs to ensure optimization of manufacturing and/or investigations as needed.

• Oversee shift operations to maintain continuous production, resolving documentation, material, and equipment issues promptly.

• Act as liaison between production and engineering management, providing updates and escalating issues as needed.

• Author and maintain production documents, templates, reports, specifications, and equipment protocols; conduct equipment qualifications and validations.

• Investigate and resolve equipment, process, and product non-conformances through root cause analysis and corrective actions.

• Develop innovative solutions to recurring production challenges and collaborate with production personnel on improvement initiatives.

• Provide training and support to production teams to enhance process understanding and efficiency.

• Partner with New Product Introduction/Transfer teams to execute calibration, process validation (IQ/OQ/PQ), and Test Method Validation (TMV) protocols.

• Design and optimize manufacturing processes, layouts, and workflows for assemblies, equipment installation, and material handling.

• Ensure compliance with regulatory requirements and incorporate inspection and test requirements into production plans.

• Monitor and improve machinery performance, initiating corrective actions to maintain product quality.

• Apply statistical process control techniques and provide guidance on design concepts to maximize equipment utilization and manufacturing efficiency.

Basic Qualifications:

• Bachelor’s degree in engineering or sciences with 4+ years of experience or a master’s degree in engineering or sciences with 2+ years of experience.

Desired Skills & Experience:

• Strong understanding of Master Validation, including Validation Master Planning, Installation Qualification, Operational Qualification, and Performance

Qualification.

• Knowledge of GD&T & experience in interpreting mechanical drawings.

• Strong communication skills, both oral and written.

• Experience with risk management, including but not limited to Process Failure Mode Effects Analysis (pFMEA), Design Failure Mode Effects Analysis (dFMEA), fault tree analysis, or other risk management tools.

• Experience in FDA 21 CFR Part 820 Medical Device Manufacturing, or ISO 13485 is preferred.

• Knowledge of Engineering Change management processes and PLM tools such as Agile, PTC Windchill is preferred. (Any PLM)

• Good interpersonal skills and ability to independently handle projects with minimal supervision.

• Ability to manage/interact with suppliers and contract manufacturers

• Medical device product development and/or manufacturing experience and a strong understanding of FDA, ICH and IEC standards

• Experience across the entire product lifecycle

TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.

DIFFERENTIATING FACTORS

Autonomy: Seasoned individual contributor.

Works independently under limited supervision to determine and develop approach to solutions.

Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact: May be responsible for entire projects or processes within job area.

Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties.

Makes improvements of processes, systems or products to enhance performance of the job area.

Analysis provided is in-depth in nature and often provides recommendations on process improvements.

Communication and Influence: Communicates with senior internal and external customers and vendors.

Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.

Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area.

May manage projects, requiring delegation of work and review of others' work product.

Required Knowledge and Experience: Requires a Baccalaureate degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years 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. 

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.

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

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 95,000+ 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)

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 95,000+ 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) .

For updates on job applications, please go to the candidate login page and sign in to check your application status.

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

To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com