Sr. Staff Product Risk Mgr.

Telford, PA, United States

The Job Responsibilities

We're hiring! If you want your contributions to make a real difference, check out this new career opportunity with us at Draeger where we are led by the guiding principle "Technology for Life".

This role is based out of our Telford, PA facility which offers its employees beautiful walking trails, onsite fitness center with yoga and fitness training classes, self-service caf with a large indoor/outdoor gathering space, and a state-of-the-art Design Center. Telford is our US manufacturing site for the Neonatal product line as well as production support for Drger's Safety products. This location also serves as the key site for essential US functions which includes Medical Sales and Service Management, Medical Marketing, Legal, Compliance, Regulatory, Quality and Finance.

Leads the risk management process throughout the development cycle, ensuring that risks are identified, control measures are defined, verified and effective, in accordance with ISO 14971 and Draeger process.Serves as corporate resource serving as spokesperson in the industry internally & externally

Creates and maintains product-related files and reports (e.g. Product Risk Management File, Product Risk Management Report, Clinical Risk Management Report, Review of Post Production Information, Essential Requirements Checklist, List of Critical Components) that support compliance efforts and enhance product safety and performance.

Reviews post-market surveillance data for Draeger and competitive products, including Draeger complaint data and publicly available adverse event databases (e.g. MAUDE) to anticipate potential issues and bring awareness to all appropriate stakeholders.

Provides leadership and expertise to product development teams at a system level and within engineering disciplines to ensure risk management principles are applied throughout the design process.Highly skilled at smart risk taking & removing impediments & inefficiencies.

Collaborates with contributing disciplines such as electronics, mechanics, software, systems engineering, algorithms, product security, clinical, usability, production, service, regulatory, and user documentation to ensure risk activities are effectively and efficiently coordinated.

Applies advanced technical knowledge and skill to influence product or system architecture and design resulting in improved product safety.Highly productive working multiple & significant assignments simultaneously.

Assesses product non-conformities and provides sound risk/benefit rationale for deferred defects.Skilled at managing & meeting commitments across projects internally & externally.

Provides product risk expertise input to Health Hazard Evaluations (HHEs) to improve responses to issues in the field; performs risk-benefit analysis and assesses and improves the risk management process resulting in improved overall product safety.

Your Qualifications

Education: Bachelor's degree in engineering or clinical discipline, Master's degree a plus.

Related Experience: 15+ years' experience in electromechanical device design

5+ years relevant experience in risk management for medical devices or other regulated industry

Experience in the field of patient monitoring a plus

Special Competencies or Certifications: A solid understanding of the potential sources of risk and how to manage risk

Broad technical knowledge in mechanics, electronics, software

Proficiency high risk management tools, including FMEA, FTA and FMECA

Knowledge of usability or human factors engineering for medical devices

Knowledge of GMPs as defined by the FDA

Knowledge in requirements management

Familiarity with UL, CSA, IEC/EN and other regulatory standards

Skilled in collaborating with multi-disciplinary teams

Master problem solver / decision maker

Innovative/creative

Leadership & coaching qualities

Strategic thinker

Results driven

The Drger Workplace

Draeger has several sites located across North America as well as field-based sales and service positions. Our North America headquarters is located in Telford, PA just north of Philadelphia. We also have US sites in Andover, MA, and Houston, TX. Our Canada site is located in Mississauga, Ontario.

Our US headquarters located north of Philadelphia in Telford, Pennsylvania is our US manufacturing site for our Neonatal product line supplying many global customers as well as production support for Draeger's Safety products. This location also serves as the key site for essential US functions which includes Medical Sales and Service Management, Medical Marketing, Legal, Compliance, Regulatory, Quality and Finance.

EEO is the Law

Draeger is an Equal Opportunity Employer. To learn more: Know Your Rights: Workplace Discrimination is Illegal (dol.gov)

Who we are

From hospitals to fire departments to industrial customers, people around the world rely on our products: cutting-edge technology that combines real engineering with the digital future. With over 130 years of experience, passion and the bold ideas of more than 16,000 employees, we are committed to turning technology into technology for life.

Benefits

Drger is responsible for life. The lives of our employees are especially important to us, therefore, Drger believes in fostering a culture that places the focus on employee health & wellbeing, both in the office and at home. We offer a generous benefits package that includes, comprehensive medical, dental & vision coverage, paid time off starting at 4+ weeks per year, tuition reimbursement, 401k match, wellness and employee support programs, life insurance and more. Drger also offers localized perks such as free parking and onsite gym with fitness instructors and classes, full-service cafeteria, and game room at select locations.