Job Abstract

Job Description

Our company’s Device Development (DD) Team designs, develops, and commercializes novel biologic/drug/vaccine - device enabled combination products to achieve safe and effective delivery to their intended site of action.  The DD Team manages the development of the device constituent of our company’s pipeline of combination products across a variety of therapy areas and routes of administration including inhalation, implantation, and injection.  

This position will be responsible for applying their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.   This position interacts extensively with subject-matter experts on the DD team and members of internal cross-functional product development teams from concept through product launch.  Additionally, the position will ensure products and processes are developed in accordance with applicable regulatory, quality, company, and customer requirements. 

This position will lead cross-functional development teams within and external to Device Development. The incumbent must be able to work well with all levels of employees and be able to effectively coordinate the execution of device development strategies. This individual will be expected to apply his/her knowledge of product design and development; manufacturing process development, qualification, and validation; and, design control and risk management techniques to positively support and influence clinical and commercial combination product development and launches.

Principal Responsibilities

Lead and set direction for the device development strategy for select development programs ranging from concept generation/selection through commercialization and launch readiness:

• Lead the Device Development Engineering Core team focused on development of design requirements for the combination product and engineering execution against the established requirements.

• Lead the cross-functional Device Working Group to ensure full integration of the device development activities with the clinical, regulatory, formulation, commercial and other key company functions.

• Represent Device Development and the project-specific Device Working Group on cross-functional teams, including the Development and Commercialization Team (DCT). Additionally, maintain engagement with Early Development Teams (EDT) and Product Development Teams (PDT)

• Serve as key point-of-contact with potential external device designers, developers, and suppliers for select device technology platforms.

• Maintain a high level of engagement in all device development activities (e.g. engineering design, engineering analysis and testing, medical device design controls, risk management, test method/fixture development, design verification and validation, injection molding, automated assembly, and human factors analysis)

• Maintain a high level of engagement in the program-specific design controls process and design history file development.

• Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership.

• Remain current in relevant worldwide regulatory guidance and standards.

• Lead/support/oversee clinical supplies production with respect to device component manufacture and final assembly of biologic/drug product with device constituent part.

• Lead/support the development, implementation and continuous improvement of Device Development and Device Project Leader processes, procedures, and tools.

• Proactively resolve project obstacles and challenges and communicate device development strategy, design controls and risk management approaches within Device Development and with external suppliers

• Enhance our Company’s professional image and competitive advantage through publications, presentations, patents, and professional activities

• Stay current with relevant regulations, technologies, standards, and effectively share this knowledge with others

Qualifications

MINIMUM REQUIREMENTS:

• B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering plus 10 years of related experience

• Leadership experience with deep working knowledge of device and/or biologic/drug product and process development including regulatory submission and approval processes.

• Has broad knowledge of medical device development, design controls and risk management

• Knowledge of U.S. and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, EN 62366, Council Directive 93/42/EEC, etc.

• Proven track record of applying analytical skills in product design, development, and evaluation

• Self-motivated and work independently

• Proven ability to lead team members of diverse skill sets and backgrounds

• Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership

• Excellent communication, presentation, negotiation, project management, and organizational skills

• Willing to travel

• Able to quickly pick up advanced domain knowledge

• Able to multi-task continuously

PREFERRED REQUIREMENTS:

• Master’s degree in one of the above disciplines plus 7 years related experience OR a PhD in one of the above disciplines plus 5 years related experience

• Experience with the development drug-device combination product or a medical device component of a combination product

• Experience with leading development projects at an enterprise level

• Experience with device design, requirement management, FMEA, design verification, design validation, statistical sampling, and control strategy

• Experience with regulatory fillings

• Working knowledge of ISO 11608 and ISO 11040

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.

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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”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range:

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.

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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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