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Manager, R&D Engineering

2 months ago

Oldsmar, Florida, United States Getinge Full time

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Function Summary:

The Manager, R&D Engineering will besponsible for technical leadership and management of engineering employees and projects, which require engineering expertise. Will lead a team of engineers to successful new product development in sterility assurance and infection control consumables.

The Manager, R&D Engineering will be responsible for the leadership of complex cross-functional projects related to the development and complete integration of Ultra Clean Systems technologies and engineering processes.

This position is an onsite role and will report to the site Managing Director. This individual will participate in the design and development of electric products.

Job Functions:

• Initiates design changes to improve product performance, reduce cost and enhance the manufacturability of commercially released medical devices.

• Supports CAPAs, NCRs and Product Complaints by investigating and addressing potential product design issues as appropriate.

• Maintains the Design History File (DHF) and Device Master Record (DMR) throughout the lifecycle of the product based on changes to the product design or manufacturing process.

• Participates in Design Reviews to ensure adequacy of the design requirements and capability of the design to meet the requirements.

• Works cross functionally on design changes, process improvement projects and quality/compliance initiatives.

• Creates and executes protocols for Design Verification and Validation activities, engineering studies and feasibility studies.

• Aids in the selection, design and evaluation of process and test equipment.

• Creates protocols and reports for process validation, test method validation, equipment qualification and gage R&R studies.

• Processes change orders to create or revise design input and output documentation.

• Performs product testing and engineering studies.

• Supports the development and revision of part specifications and other design documentation.

• Mentors and develops the team.

• Manages day-to-date activities of the team and assigns tasks based on priority.

• Contributes to the team effort by accomplishing related tasks as needed.

Required Knowledge, Skills and Abilities:

• Demonstrated ability to solve technical challenges with cross-functional teams.

• Strong analytical, problem solving and communication skills.

• Strong communication and collaboration skills.

• Self-motivated, with the ability to accomplish project goals with minimal supervision.

• Experience with Agile PLM and Minitab desired.

• Knowledge of Good Documentation Practices (GDP) required.

• Experience in communicating (both orally and written) to all levels of the organization.

Minimum Requirements:

• Bachelor's degree in Engineering or scientific discipline, such as electrical or mechanical engineering.

• A minimum of four years' experience in the medical device industry with relevant experience in design control, production and process controls and/or R&D or related areas.

• A minimum of two years of management experience.

• Knowledge of 21 CFR Part 820 and standards relevant to medical devices.

• Experience in leading projects or activities in groups.

• Strong experience with Microsoft Office applications (Word/Excel/Power Point) is required.

Quality Requirements:

• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations.

• Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations.

• Attend all required Quality & Compliance training at the specified interval.

• Adopt the "Beyond Compliance Quality Culture" in the work environment; always meet and exceed requirements.

Environmental/Safety/Physical Work Conditions:

• Responsible for understanding and conforming to the Environmental Policy to ensure that significant environmental aspects that relate to actual or potential impacts with their work are executed to minimized the effects on the environment.

• Responsible for bringing to the attention of management any potential improvements that could reduce our environmental impact or to report activities that could result in a negative impact to the environment.

• Responsible for understanding and conforming to the Health and Safety Policy to ensure that the significant risks that relate to actual or potential hazards with their work are identified.

• May work extended hours during peak business cycles.

• While performing the duties of this job, the employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 75 pounds.

• Specific vision abilities required by this job include color vision. Possible visual color matching of ink products may be necessary, as well as the moving of ink containers and/or raw material containers.

• While performing the duties of this job, the employee has the potential to be exposed to fumes, airborne particles, toxic or caustic chemicals. The employee is occasionally exposed to moving mechanical parts. The noise level in the work environment may be loud.

• Position requires work with organic solvents which have potential for vapor exposure although proper protective equipment is provided. Also, there is noise from production areas when exposed and mixers in milling room. OSHA standards on Safety and PPE are followed.

• Must wear appropriate PPE as required per job. Hearing necessary to receive and reply to outside contacts and employees. Ability to speak clearly in order to communicate with customers, vendors and employees in person.

• Must be willing to work in both sitting and standing positions for long periods of time, up to 8 hours per shift. Willingness to frequently move to various locations within building.

The physical demands described here 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.

Permissions:

Each organization shall establish the appropriate authority, and interrelation of all employees who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.

Supervision/Management Of Others: Manages a team of approximately 3-4 R&D Technicians.

Internal and External Contacts/Relationships:

• Main contacts, internal;

o Executive Management Staff

o Operations Management and Staff

o Supply Chain Management and Staff

o Marketing Management and Staff

o QA/RA Management and Staff

o Finance Management and Staff

o Sales Management and Staff

• Main contacts, external;

o Key Opinion Leaders

o Surgeons/ SMEs

o Customers

o Critical Suppliers

o Contract Design Houses

• OEM Customers

Disclaimer:

The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

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About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Benefits at Getinge:

At Getinge, we offer a comprehensive benefits package, which includes:

  • Health, Dental, and Vision insurance benefits
  • 401k plan with company match
  • Paid Time Off
  • Wellness initiative & Health Assistance Resources
  • Life Insurance
  • Short and Long Term Disability Benefits
  • Health and Dependent Care Flexible Spending Accounts
  • Commuter Benefits
  • Parental and Caregiver Leave
  • Tuition Reimbursement

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.