At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll 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 95000 employees including 13500 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 2700 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 were 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:
Bachelors degree in engineering or sciences with 4 years of experience or a masters 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 degreeand minimum of 4 years of relevant experience OR Masters 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.

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 95000 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