Distinguished Scientist, Device Tech & Eng Lead, Drug/ Device Combo

Job Description

Our company's Device Product & Process Development (DPPD) Team within our Device Development & Technology (DD&T) organization 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 and commercialization of the device constituent and combination product 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 serves as a senior individual contributor who will be responsible for applying deep subject-matter expertise and knowledge of product and process development in the (bio)pharmaceutical and medical device industries to set tactical and strategic direction on programs to ensure delivery of high-quality products, test methods, and robust manufacturing processes for both clinical and commercial use. This position interacts extensively with subject-matter experts within the broader DD&T team (e.g. design verification, device risk management, human factors, technical integration, assembly automation, etc.), as well as members of internal cross-functional product development teams from concept through product launch. The ideal candidate will possess extensive knowledge in medical device engineering, particularly in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products.

The incumbent must be able to lead cross-functional development teams within DD&T and across our company, and work well with all levels of employees to develop and seamlessly coordinate the execution of device development strategies. This individual will be expected to apply their knowledge of product design and development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and influence clinical and commercial combination product development and launches. The incumbent must also be highly adept at presenting and reviewing device and combination product strategies and development efforts in senior-level governance reviews.-Furthermore, the successful candidate will spend time mentoring and coaching other Device Technical and Engineering Leaders, assisting them in navigating their development programs.

Primary 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 Combination Product Working Groups to ensure full integration of the device development activities with the clinical, regulatory, formulation, commercial and other key company functions.
    
  • Lead the Device Engineering Sub-Teams focused on development of design requirements for the combination product and engineering execution against the established requirements.
    
  • Represent Device Development & Technology and the project-specific Combination Product Working Groups on cross-functional teams at the highest-level CMC teams and governance.
    
  • Serve as key point-of-contact with potential external device designers, developers, and suppliers for selected device technology platforms.
    
• Oversee and serve as an 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 Technical & Engineering 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.
  

Education Requirements - One of the following (advanced degree is preferred) :

• BS/ BA degree in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering with a minimum of 20 years of combined experience in medical device and combination product development.
  
• MS/ MA degree in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering with a minimum of 18 years of combined experience in medical device and combination product development.
  
• PhD degree in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering with a minimum of 15 years of combined experience in medical device and combination product development.
  

Required Experience and Skills:

• Broad knowledge of medical device and combination product development, design controls and risk management, alongside deep knowledge in device design, requirement management, design verification, automation/process development, design validation, human factors evaluations and control strategy.
  
• Deep and broad working knowledge of pharmaceutical vaccine/biologic/small molecule drug product and process development including regulatory submission and approval processes
  
• 10+ years of leadership experience of managing complex device or combination product development programs at an enterprise level and leading cross-disciplinary project teams.
  
• Proven track record of applying analytical skills in product design, development, and validation.-
  
• Proven ability to lead team members of diverse skill sets and backgrounds.
  
• Proved ability to manage and navigate external suppliers and development partners
  
• Strong interpersonal skills with excellent communication, presentation, negotiation, project management, and organizational skills.
  
• Willing to travel.
  

Leadership Competencies :

• Strategic Planning: Develop long-term strategies that align with organizational goals and drive measurable technical and business results.
  
• Decision Making : Strong analytical skills to evaluate complex technical issues and make informed and decisive decisions.
  
• Emotional Intelligence : Build trust and foster relationships across scientifically/ technically diverse disciplines, teams, and organizations.- Promote and role model collaborative and transparent ways of working.- Adjust communication approaches during interacting with teams, stakeholders, and governance committees.
  
• Innovation : Encourage experimentation and the development of novel solutions to enhance product performance and customer satisfaction.
  
• Enterprise Mindset: Embrace an enterprise and robustness at launch mindset, making disciplined decisions for the good of the business.
  
• Networking and Partnerships: Cultivate internal and external strategic relationships across the industry to drive the advancement of understanding scientific/ technical issues to achieve business goals.
  
• Influence: Create and execute strategies to gain commitment to ideas that ignite actions to advance shared interests and business goals across stakeholders. Able to influence without formal authority; ability to influence and present ideas to senior leadership.
  
• Motivation and Inspiration: Propels self and others toward higher levels of performance that are aligned with the organization's purpose and goals.-
  

Preferred Experience and Skills:

• Deep subject-matter expertise in both parenteral and ocular delivery product design and delivery device technologies, including the design requirements of the associated primary container systems.
  
• Strong external networks and familiarity with the viable organizations offering ocular and parenteral delivery device components and platforms.
  
• Deep understanding of clinical and commercial manufacturing requirements for sterile drug products, as well as combination product assembly processes.
  
• Extensive 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.-
  
• Additionally possess extensive knowledge in traditional worldwide pharmaceutical regulations including but not limited to 21CFR210, 211, 600-680, ICH Q8/9/10, Directive 2001/83/EC and comparable worldwide regulations.
  

Current Employees apply HERE

Current Contingent Workers apply HERE

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- 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 together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

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 salary range for this role is
$206,200.00 - $324,600.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

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/International

VISA Sponsorship:
Yes

Travel Requirements:
25%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
N/A

Required Skills:
Biomedical Engineering, Clinical Development, Combination Products, Cross-Disciplinary Collaboration, Device Development, Executive Communications, Executive Presence, Executive Presenting, Health Information Exchange, Human Factor Engineering, Industrial Engineering, Intellectual Curiosity, Pharmaceutical Development, Product Development, Product Lifecycle Management (PLM), Project Management, Regulatory Interactions, Regulatory Oversight, Risk Management, Scientific Leadership, Stakeholder Management, Strategic Leadership

-Preferred Skills:

Job Posting End Date:
08/26/2025
*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: R358809