Senior Scientist - Design Control (Hybrid)

HireLifeScience; Rahway (NJ); Hybrid; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical, dental, vision

Retirement benefits (401(k))

Paid holidays and vacation

Sick days

Job summary

Merck & Co., Inc., Rahway, NJ, USA is seeking a Senior Scientist, Device Design Control Lead to spearhead design controls for combination product development and lifecycle management. You will collaborate with cross-functional teams to ensure high-quality devices and efficient manufacturing throughout the product lifecycle, from concept through launch and post-market activities.

The role requires 6+ years in pharmaceutical or device development, strong regulatory knowledge, and proven analytical

Qualifications

• Minimum of 6 years of experience in pharmaceutical development, device development, device systems operations, quality management, or a related area.
• Strong knowledge of regulatory requirements and industry standards related to device systems.
• Strong analytical and statistical skills with experience in data interpretation and risk assessment tools.
• Excellent communication, leadership, and problem-solving skills.

Responsibilities

• Lead and contribute device development design controls for the assigned projects.
• Prepare materials for program presentations for management review and regulatory submissions.
• Lead the implementation and/or ensure effective execution of the device development strategy and design controls
• Proactively resolve project obstacles and communicate device development strategy and design controls approach within Device Development and with external suppliers.
• Understand and apply regulatory / compliance requirements relative to design controls and risk management activities.
• Contribute to the development, implementation, and continuous enhancement of device design control processes, procedures, and tools.
• Participate in the strategic development of the Device Design Control function, contributing to team goals and initiatives.

Skills

Analytical Method Development

External Partners

GD&T

ISO 13485 Medical Devices

Manufacturing Processes

Mechanical Design

Mechanical Testing

Method Validation

Product Development

Prototyping

Statistical Analysis

Teamwork

Technical Writing

Education

B.S. or master's degree in Engineering, Science, or a related field

Job description

Job Description

The Senior Scientist, Device Design Control Lead , is a crucial member of our team, responsible for spearheading design control efforts in combination product development, commercialization, and lifecycle management. This individual will oversee device design control activities to ensure the delivery of high-quality products and efficient manufacturing processes. The role requires extensive collaboration with subject-matter experts across various cross-functional combination product development teams throughout all phases of the product lifecycle, from concept through launch and post-market surveillance.

Key Responsibilities and Activities:

• Lead and contribute device development design controls for the assigned projects.-
• Prepare materials for program presentations for management review and regulatory submissions, ensuring clarity and thoroughness.
• Lead the implementation and/or ensure effective execution of the device development strategy and design controls for the assigned projects while adhering to management-approved strategic plans, corporate policies, and providing clear communication to cross-functional stakeholders, including external suppliers.
• Proactively resolve project obstacles and challenges and communicate device development strategy and design controls approach within Device Development and with external suppliers.
• Understand and apply regulatory / compliance requirements relative to design controls and risk management activities.
• Contribute to the development, implementation, and continuous enhancement of device design control processes, procedures, and tools.
• Participate in the strategic development of the Device Design Control function, contributing to team goals and initiatives.

Minimum education required:

• B.S or master's degree in Engineering, Science, or a related field plus 6 years of related experience.

Required experience and skills:

• Minimum of 6 years of experience in pharmaceutical development, device development, device systems operations, quality management, or a related area.
• Strong knowledge of regulatory requirements and industry standards related to device systems.
• Strong analytical and statistical skills with experience in data interpretation and risk assessment tools.
• Excellent communication, leadership, and problem-solving skills.
• Ability to work in a dynamic and fast-paced environment, managing multiple priorities effectively.

Required Skills:

Analytical Method Development, External Partners, Geometric Dimensioning And Tolerancing (GD&T), ISO 13485 Medical Devices, Manufacturing Processes, Mechanical Design, Mechanical Testing, Method Validation, Product Development, Prototyping, Statistical Analysis, Teamwork, Technical Writing

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

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:

EEOC Know Your Rights

EEOC GINA Supplement

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

Salary range:

$117,000.00 - $184,200.00

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 https://jobs.merck.com/us/en/compensation-and-benefits .

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

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:

10/12/2026

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:

R420263