Job Description
Job description
This position will be responsible for leading and implementing medical device and combination product design controls for both new products and inline products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance. The role will also be responsible for leading and supporting continuous improvement initiatives related to design control and risk management processes for combination products. This includes identifying process inefficiencies using operational excellence tools and ensuring alignment with global regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 14971).
This position will interact with 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 and drive continuous improvement in design control and risk management processes. This individual will be expected to apply his/her knowledge of product development and design control principles to positively support and influence clinical and commercial combination product development and launches to ensure they are developed and manufactured in accordance with regulatory, company, and customer requirements.
Principal Responsibilities
- Lead/Support continuous improvement initiatives for design control and risk management processes
- Identify and eliminate process inefficiencies using operational excellence tools
- Develop training materials to foster a culture of operational excellence
- Ensure processes align with regulatory requirements for medical device and drug combination products (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 14971)
- Collaborate with cross-function teams to improve processes related to device-drug integration.
- Partner with Quality and Regulatory teams to ensure compliance with applicable global regulations.
- Leverage data analytics and key performance indicators to monitor process performance.
- Support internal audits, regulatory inspections, and third-party audits.
- Conduct structured assessments of key quality and compliance programs to identify gaps against internal standards, regulatory expectations (e.g., FDA, EMA), and industry best practices, generate action plans and drive the plan to closure. Develop actionable remediation plans and drive their execution through to closure.
- Lead/contribute to device development, design controls for the assigned projects.
- 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.
Position Qualifications:
Education Minimum Requirement:
B.A./B.S. in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering plus 15 years of related experience or master’s degree in one of the above disciplines plus 12 years related experience
Required Experience and Skills:
- 10+ years of experience in process improvement, Quality management system, operational excellence, and product development
- Has broad knowledge of combination product/medical device development, design controls, and risk management
- Hands-on experience with combination products
- Proven track record of driving lean and six sigma initiatives in a regulated environment
- Led and managed development of DHF (design history file) deliverables for combination products and/or medical devices
- Knowledge of U.S. and global combination product/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.
- Self-motivated with the ability to work independently.
- Experience with FMEA, statistical sampling, and control strategy.
- Proven ability to work with team members of diverse skill sets and backgrounds.
- Strong analytical and problem-solving abilities.
- Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership.
- Demonstrated experience leading and supporting change initiatives, with a strong track record of driving process improvements and fostering cross-functional collaboration to achieve sustainable results.
- Excellent communication, presentation, negotiation, project management, and organizational skills.
Preferred Experience and Skills:
- PMP or similar project management certification
- Quality Engineering Certification
- Six Sigma Certification
- Experience with device design, process development, design verification, and design validation
**Required Skills: **
Biomedical Engineering, Combination Products, Device Development, Process Development Engineering, Process Improvements, Product Development
**Preferred Skills: **
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.
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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 salary range for this role is
$153,800.00 - $242,200.00
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.
You can apply for this role through https://jobs.merck.com/us/en (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
VISA Sponsorship:
Yes
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
05/16/2026
***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. **