C

Principal Chemist

COV Covidien LP
Full-time
On-site
USA-CT North Haven United States of America
We anticipate the application window for this opening will close on - 7 Mar 2025


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

This individual will work closely with program/project cross-functional teams to develop cleaning validation strategy, reviewing current design documentation, providing gap assessments and update reports as required to remediate in accordance with international standards such as ISO 17664, ANSI/AAMI ST98, ISO 15883-5, and European medical device regulations, to support the regulatory submission of implantable and non-implantable products within Medtronic’s Surgical Operating Unit (OU).

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

  • Participates in the creation and implementation of cleaning cycle development strategies for a variety of reusable medical devices including Class II and/or III devices, to achieve optimal solutions that satisfy timeline, cost and technical requirements as they relate to biological safety.
  • Maintains an up-to-date knowledge of validation requirements, practices, and procedures.
  • This role involves close collaboration with various departments to ensure compliance with regulatory and customer requirements while implementing effective cleaning strategies across the Medtronic Surgical Operating Unit.
  • Provides oversight of cleaning validation lifecycle maintenance that includes establishment of validation document hierarchy, tracking execution work arising from NPD and RPE programs, and management of the revalidation within new geographies.
  • Participates in the pilot program to liaise with internal resources (design, regulatory, quality, clinical and manufacturing) and with Medtronic’s Physiological Research Laboratory’s Cleanability Lab group, developing and coordinating test strategies to ensure appropriate planning and execution of required testing.
  • Participates in the analysis of technical issues and the development of recommendations for project decisions and actions.
  • Communicates and potentially escalates critical issues to key stakeholders that impact product design, schedule.
  • Performs gap assessments of products by reviewing legacy documentation and evaluating device BOMs to determine the applicability of test data to ISO 17664, ANSI/AAMI ST98, ISO 15883-5, and European medical device regulations and standards.
  • Assists in regulatory submission responses to cleaning validation questions.
  • Ensures alignment of intelligent risk taking within Surgical OU.
  • Influences organization excellence by recommending approaches, procedures, and work aids as they relate to biocompatibility, in compliance with applicable global regulatory requirements.

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: 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.

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.

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.

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.

Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area.
Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.

Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
May have broad knowledge of project management.
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):$126,400.00 - $189,600.00

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).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

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.

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.