Remote R&D Engineer Medical Device Jobs in Rutherford, NJ

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.

This role is open to US and EUR based candidates
Compensation depending upon location

Job Overview

The Corporate Medical and Chief Safety Officer (CMCSO) leads the Corporate Medical function at Getinge, responsible for developing and leading the company-wide Safety function and processes, serving as the Medical & Safety Director for Surgical Workflows, and leading the Medical Education group.  This role will ensure that medical safety input to product and process decisions is made in a consistent, thoughtful, and evidence-based structure.  This role ensures that all medical device development, regulatory submissions, and post-market activities are grounded in clinical evidence, aligned with patient safety, and compliant with global healthcare standards. The CMO plays a critical role in building a strong, flexible, and capable direct as well as virtual organization, supporting new product and especially fielded product safety across the enterprise, leading Medical Education and any other shared medical services that might be added in the future, serving as the medical and safety director for Surgical Workflows, and  serving as a key voice of the clinician and patient within the company.

Job Responsibilities and Essential Duties

• The Corporate Medical Officer coordinates the team of Medical Professionals within Getinge to ensure compliance. He/she provides expert medical opinions and recommendations as requested to all departments including Quality and Compliance, Regulatory Affairs, R&D, marketing, and clinical research, and provider training.

• Responsible to support and where needed, create consistent and clear Medical Safety process across the Getinge businesses, in collaboration with the team of Medical Officers

Product Safety

• Advises as needed to medical affairs teams, product teams  and the quality assurance group for review of product complaints, MDR reporting criteria, health risk assessments, and product performance criteria.
• Ensures medical management of post-marketing adverse events and medical oversight of safety projects.

In coordination with PA medical personnel, personally conducts medical review and signature of safety reports and associated QA documentation.

• Works closely with the Quality, Compliance and Regulatory teams to improve processes & decision criteria to analyze adverse events.  Serves as escalation point when needed to help formulate an appropriate response back to the customer as well as if required the Food and Drug Administration, notified bodies, or other regulatory authorities.
• When requested, can represent the Company with regulatory and legislative agencies, globally addressing the scientific and medical/health aspects of our product portfolio.

Advance R&D: 

When requested by BA Medical teams, or in cases of due diligence on technologies where we do not have depth of internal Safety expertise:

• Reviews as independent reviewer on internal new technology/products ideas; -
• Independent safety and for SW, medical l opinion during early-stage evaluation of external opportunities to support strategic initiatives of Business Development team (when needed, in collaboration with BA medical teams). 
• Supports processes for the application of new technologies in novel ways to solve complex medical device needs.
• Maintains up-to-date knowledge of surgical trends, advances, efficacy of currently available therapies and competitive clinical landscape.
• As requested, provides medical safety input to legal counsel on product litigation, claims management, investigations, and other matters demanding medical expertise.

Clinical Studies:

• Ensures documented Safety procedures within Getinge on clinical protocols, clinical study-related documents, and clinical study reports.

Medical Education:

• Manages a team of clinicians tasked to develop and implement customer and patient focused product & clinical education programs.
• Reviews or finds appropriate independent reviews for product education, promotion, and reporting materials.
• As needed, Attends National, International, and regional meetings in collaboration with BA plans

Quality System:

• Comply with quality system requirements as defined globally within Getinge, as applicable.
• Responsibility and authority to propose and drive corrections and improvements within the safety and in collaboration with other medical affairs team members, medical affairs & clinical affairs area globally.
• Responsibility and authority to act on corrections to Getinge and regulatory policies and procedures.

Minimum Requirements

• Medical degree is required.
• Minimum of 10 years of clinical experience, with at least 5 years in the medical device industry or related healthcare technology field.
• Proven experience in Medical Safety
• Excellent communication, leadership, and cross-functional collaboration skills.
• Strong executive presence. Demonstrated ability to present to and engage at the senior most level of the organization.
• Influence skills.  Able to work with other medical professionals, business people, regulator affairs, legal, and external stakeholders in a collaborative and convincing way
• Patient-focused mindset. Mission-driven, with passion for improving the lives of patients and their families

Required Knowledge & Skills

• Experience in Getinge-related therapies
• Strong background in medical safety
• Familiar with clinical research, device development process, regulatory requirements, laws and good clinical practices
• Understanding of statistical methods
• Effective written & oral communication skills, with the ability to communicate effectively to scientific and non-scientific groups
• Strong organizational and interpersonal skills.
• Proven presentation skills
• Strong sense of integrity, responsibility, and urgency
• Evidence of a management style characterized by leadership, vision, collegiality, teamwork, preparation, and communication
• Flexibility and ability to manage simultaneous priorities, changing deadlines, and limited resources
• Models Getinge's behaviors as established policies and procedures
• Strong in conducting and follow up/ execution
• Leading through others and by participation
• Write and understand complex contexts and translate into policies etc.
• Like to educate and train other (team player)
• Regulatory requirements and standards applicable where Getinge operate

Travel requirements include 50% domestic and international travel.

US BASED SALARY - The minimum base salary for this position is $286,000 and the maximum salary is $360,000  plus  40% in annual bonus, Company Vehicle.

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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.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.