Job Description

Our company's Device Product & Process Development (DPPD) 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 DPPD 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.

Job description

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 DPPD 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 & Technology. 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 multiple drug-device combination product development programs ranging from concept generation/selection, development, verification, and validation to launch readiness:

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

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

  • Represent Device Development and the project-specific Device Working Groups 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 selected device technology platforms.

• Oversee and serve as a technical integrator of all device development activities including 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.

• Proactively anticipate and resolve project obstacles and effectively communicate complex product technical challenges, device development strategy, timelines, milestones, and risks within our Company and with external suppliers

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

• 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.

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

• Stay current with new device technologies, relevant worldwide regulations, standards, and effectively share this knowledge with others.

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

Qualifications

REQUIREMENTS:

• B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering plus a minimum of 10 years of combined experience in medical device and combination product development. Advanced degree is preferred.

• Leadership experience with working knowledge of device, biologic/drug product, and process development including regulatory submission and approval processes. Including development drug-device combination product or a medical device component of a combination product.

• Leadership experience of managing device or combination product development programs and leading cross-disciplinary project teams.

• Has broad knowledge of medical device development, design controls and risk management, alongside deep knowledge in device design, requirement management, design verification, automation/process development, design validation, and control strategy.

• 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, 11608 and 11040, EN 62366, Council Directive 93/42/EEC, etc.

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

• Self-motivated with ability to 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

• Experience with leading complex development projects at an enterprise level

• Willing to travel

• Able to multi-task continuously

Current Employees apply HERE

Current Contingent Workers apply HERE

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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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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.

Expected US 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.

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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Requisition ID:R328387