Sr. Director, Drug/Device Combination Products, Device Product Stewardship

Job Description

The Senior Director of Device Product Stewardship will lead a department of up to 15-20 personnel overseeing technical support and product stewardship for our company’s medical device and combination products (approximately 15 in total).

This strategic leadership role will ensure that the portfolio overall and each product has robust lifecycle management plans, appropriate and rigorous technical support processes to support manufacturing sites, proactive risk management, performance monitoring, continuous improvement activities that ensure the safety, effectiveness, and compliance of the company's products.  The organization 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 Senior Director will ensure stewards have the appropriate processes and playbooks, appropriate oversight, and that these processes communicate and align and collaborate with cross-functional teams, manufacturing sites, clinical safety and risk management to uphold the highest quality standards and drive innovation in product stewardship.  As a key senior member of the team, the role requires communication, influence, and alignment across multiple business units and sites within the manufacturing division.

Key Responsibilities:

1. Lead and provide strategic vision to the technical product stewardship department, overseeing technical support and product stewardship activities for approximately 15 inline medical device and combination products.  Ensure staff has deep technical and leadership capabilities and processes to enable world class proactive manufacturing processes and rapid issue identification and resolution.

2. Direct the development and implementation of proactive risk management strategies, including risk assessment, risk mitigation, and risk communication, to ensure the ongoing safety and efficacy of the company's product portfolio. 

3. Collaborate with cross-functional partners, including R&D, Quality, Regulatory, Manufacturing, Technical Product Leaders, and Value Chain to ensure comprehensive and effective technical support and product stewardship for inline products.

4. Develop and maintain key performance indicators (KPIs) to measure the effectiveness and efficiency of technical support and product stewardship activities, and drive performance improvements as needed, such as the in process and release data, process health index, CAPA effectiveness, and complaint measures.

5. Ensure standard work and processes, and drive continuous improvement initiatives to enhance technical support processes, optimize supply chain efficiencies, and improve product stewardship practices, while ensuring compliance with regulatory requirements.

6. Foster a culture of excellence, mentorship, and professional development within the technical product stewardship department, ensuring the growth and effectiveness of the team.

7. Interface with regulatory authorities, industry organizations, and external partners to stay abreast of relevant regulations, standards, and best practices, and to represent the company's technical product stewardship capabilities.

Qualifications:

• Bachelor's degree in engineering, life sciences, or related field. Advanced degree (Master’s or PhD) preferred.

• 15+ years of experience in medical device engineering, combination product development, or related technical fields, with a minimum of 5 years in a leadership or senior management position. 

• Proven track record of effectively leading and managing a team supporting 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.

• Significant experience in analytical method development and validation, including experience with a variety of analytical and materials characterization tools and techniques

• Extensive knowledge of technical and global regulatory requirements for medical devices and combination products, including FDA, EU MDR, ISO, and other applicable guidelines. 

• Excellent communication, negotiation, interpersonal skills, and problem-solving skills, with the ability to effectively engage with internal and external stakeholders and industry partners.

• 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.

• Ability to drive change and lead teams in a fast-paced and dynamic environment.

PSCS

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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, Monday - 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.

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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.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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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. 

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