Job Description
Job Summary: The Director of Device Product Stewardship will be responsible for leading technical support and product stewardship for several key products in our company’s medical device and combination products portfolio. This role will ensure the development and execution of robust lifecycle management plans, proactive risk management strategies, and continuous improvement initiatives to guarantee the safety, effectiveness, and compliance of our company's product portfolio. The product steward will ensure post-market complaint technical oversight and rapid responses to early signals and trends with effective and statistically sound CAPA plans and issue resolution. The Director will lead a team of technical experts and drive continuous improvement through proactive risk management and robust technical support processes. The Director will collaborate with cross-functional teams, manufacturing sites, and internal and external stakeholders to uphold the highest quality standards and drive robust product performance.
Essential Duties and Responsibilities:
- Provide strategic leadership and direction for technical support and product stewardship across assigned products, including managing ongoing changes to medical device and combination product designs and manufacturing processes. Develop, maintain, and refine technical product lifecycle management plans.
- Collaborate with cross-functional teams to ensure that all products meet safety, efficacy, and quality, and robust supply standards throughout their lifecycle.
- Lead, mentor, and develop a team of technical staff, providing guidance on industry best practices and fostering a culture of continuous improvement.
- Oversee lifecycle changes for products, ensuring internal quality and technical requirements are achieved, and ensure filings with regulatory bodies to ensure compliance with relevant regulations and standards, including FDA, EU MDR, ISO, and other applicable guidelines.
- Drive proactive risk management activities, including risk assessment, risk mitigation, and risk communication strategies.
- Develop and maintain strong relationships with internal stakeholders, including R&D, quality, packaging, analytical, regulatory, manufacturing, Technical Product Leaders and Value Chain to facilitate effective technical support and product stewardship. This includes above site support for significant investigations, complaints monitoring (hypercare) and rapid response activities.
- Develop and maintain key performance indicators (KPIs) to measure and improve the effectiveness of technical product stewardship activities.
Qualifications:
Minimum education required:
Bachelor's degree in engineering, life sciences, or related field. Advanced degree (Master’s or PhD) preferred. 10+ years of experience in medical device engineering, combination product development, or related technical fields.
Required experience and skills:
- Demonstrated experience in a leadership role, managing technical product stewardship, supply, or related functions.
- Strong understanding of medical device and combination product development and support from early stage through launch and supply, including mechanical systems design and manufacture, medical device design controls and device risk management, human factors evaluations, and design verification/validation.
- In-depth knowledge of global regulatory requirements for medical devices and combination products.
- Strong understanding of risk management principles, including ISO 14971 and other relevant standards.
- Excellent communication and interpersonal skills, with the ability to effectively engage with internal and external stakeholders.
- Proven track record of driving continuous improvement and implementing best practices in technical support and product stewardship.
- Strong strategic and analytical thinking, with a focus on driving continuous improvement and implementing best practices in technical support and product stewardship.
- Professional certifications (e.g., RAPS, ASQ, Six Sigma) and familiarity with statistical process control and improvement are highly desirable.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected US salary range:
$149,400.00 - $235,100.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status: Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
10/10/2024
- A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R314322
