Medtronic Jobs

Careers that Change Lives

In this role, you will join a world class team of mechanical, electrical and software engineers within the Medtronic’s Surgical Operations Unit. This is one new, powerful operating unit bringing together the people and product portfolio of Surgical Robotics and Surgical Innovations. With the Medtronic Mission as our North Star, we will build on our legacy of proven surgical solutions and advance the promise of robotics and digital solutions for the benefit of the customers and patients we serve.

Make your impact by exploring a career with the world’s leading Medical Device company, striving “ to alleviate pain, restore health, and extend life.”

Location: New Haven, CT (Open to remote in the U.S.)

Travel up to 20% Domestic

A Day in the Life

Responsibilities may include the following and other duties may be assigned:

· Partners with staff in the implementation and maintenance of policies and procedures aligned with relevant global regulations and standards.

· Partners with Corporate Clinical Quality & Compliance partner in performing support to Clinical Operations team.

· Manages clinical training curriculum associated with standard operating procedures.

· Acts as an advisor on clinical quality assurance issues regarding various aspects of the clinical study phases (e.g. patient informed consent forms, investigational plans and amendments).

· Completes audits to assess accuracy and quality of scientific data submitted to the regulatory agencies in support of new drug application, biological licensing agreement, animal drug application or medical devices application.

· Conducts and performs investigations to ensure conformance to regulations and company standard operating procedures.

· Documents audit observations and makes recommendations for corrective and preventive action.

· May create and maintain clinical quality assurance databases, reports, and files.

· Performs quality reviews and tracks corrective and preventive actions until closure.

· May act as an advisor on clinical quality assurance protocol, amendments and/or biological licensing agreements.

· May also audit operating systems, processes, and procedures.

· May support risk management operations, including ongoing review of literature and compilation and interpretation of safety data to support product strategies.

· May plan and prepare report drafts for products, compliance statements, audit certifications, and safety issues for regulatory submission.

· May use six-sigma methodology.

· May provide training on GCP and current regulations for those undertaking clinical studies.

· Assists study teams in being audit ready at all times by performing Trial Master File reviews and providing training on Good Clinical Practice and current regulations as needed.

· Helps establish and track quality performance measurements and may support reporting to management, including conducting Clinical Quality Functional Reviews (CQMR) on a quarterly basis.

· Supports preparation for Management Reviews.

· Performs quality reviews and tracks corrective and preventive actions until closure.

Responsibilities may include the following and other duties may be assigned.

• Completes audits to assess accuracy and quality of scientific data submitted to the regulatory agencies in support of new drug application, biological licensing agreement, animal drug application or medical devices application.

• Conducts and performs investigations and ensures conformance to regulations and company standard operating procedures.

• Documents audit observations and makes recommendations for corrective and preventive action.

• May create and maintain clinical quality assurance databases, reports, and files.

• Performs quality reviews and tracks corrective and preventive actions until closure.

• May act as an advisor on clinical quality assurance protocol, amendments and/or biological licensing agreements.

• May also audit operating systems, processes and procedures.

• May support risk management operations, including ongoing review of literature and compilation and interpretation of safety data to support product strategies.

• May plan and prepare report drafts for products, compliance statements, audit certifications, and safety issues for regulatory submission.

• May use six-sigma methodology.

• May provide training on GCP and current regulations for those undertaking clinical studies.

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

· Degree in engineering, life sciences, or related medical/scientific field.

· CCRA certification (Certified Clinical Research Association), ACRP, CCRP, SOCRA, or equivalent preferred.

· Experience with Good Clinical Practice (GCP), ISO14155 and/or regulatory compliance guidelines for clinical trials/data collection.

· Ability to appropriately apply different standards related to medical devices/ clinical research (SOPs, GCP, ISO, ICH, FDA, MedDev, etc.), as needed.

· Experience with audits/compliance within clinical/quality/regulatory and regulatory inspections (e.g., FDA – BIMO, Notified Body (Europe)).

· Ability to incorporate and adhere to applied standard practices and regulatory standards.

· Experience with Corrective and Preventive Action (CAPA).

· Experience in clinical quality assurance at Medtronic or within a medical device industry.

· Clinical Research experience at Medtronic or within the medical device industry or pharmaceutical industry.

· Experience in sponsor-initiated clinical trial experience managing clinical site personnel.

· Experience working with the clinical study lifecycle (e.g., planning, execution, and closeout).

· Experience/education in project/program management and/or continuous improvements to processes and procedures.

· Specialist career stream: Typically an individual contributor with responsibility in a professional discipline or specialty. 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 and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

· Differentiating factors:

o Autonomy: Recognized expert, managing large projects or processes. Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager. Coaches, reviews and delegates work to lower-level specialists.

o Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results. May manage large projects or processes that span outside of immediate job area.

o Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation. Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems.

o Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels. May negotiate with others to reach understanding or agreement, and influence decision-making.

o Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area.

o Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

Min Salary

121600.0

Max Salary

182400.0

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.