Requisition ID: PRE000743
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century . Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company. Today, we're doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
This position will be a high level, individual contributor role in the Device Development team.
Position reports to the Director of Device Development, responsible for leading and implementing Medical Device and Combination Product Design Control and Risk Management activities for both inline products and new products from early design concept definition through commercialization.
This position will interact with cross-functional development teams and within 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.
The main activities will include developing and documenting medical device and combination product design history files to ensure compliance with Medical Device (21CFR 820s) and Combination Product current Good Manufacturing ruling (21CFR part 4), Device Risk Management (ISO 14971) and other worldwide regulations and Merck requirements. This individual will be expected to apply his/her knowledge of product development, design control principles and risk management techniques to positively support and influence commercial and new medical device and combination product development launches to ensure they are developed and manufactured in accordance with regulatory, company, and customer requirements.
Primary activities include, but are not limited to:
• Lead the Design Control and Risk Management strategy for the assigned projects within Device Development
• Facilitate project lead to supervise the whole project movement, proactively identify issues, herd team to explore possible solutions and fill in gaps as necessary
• Lead, implement and ensure effective execution of the Design Control and Risk Management activities for the assigned projects while adhering to management approved strategic plans, corporate policies, and providing clear communication within and external to the team, including external suppliers.
• Lead the implementation and communication of Design Control and Risk Management procedures within Device Development and with external suppliers as assigned
• Understand and apply regulatory / compliance requirements relative to Design Control and Risk Management activities.
• Lead the preparation of materials for presentation of programs for management and regulatory submission
• Support the development, implementation and continuous improvement of Design Control and Risk Management processes, procedures and tools
Education Minimum Requirement:
A Bachelor's degree in (Science or Engineering or associated fields)
Required Experience and Skills:
• A Bachelor's degree in (Science or Engineering or associated fields) with a minimum of 10 years related experience OR a Master's degree (Science or Engineering or associated fields) and 7 years related experience OR a Ph.D. (Science or Engineering or associated fields) and 5 year of related experience. Advanced degrees may be used reduce required experience.
• Led and managed development of DHF (design history file) deliverables for medical devices.
• Extensive knowledge of applicable medical device regulations (21CFR820, MDD, ISO 13485).
• Experience with Design Controls / CAPA / Purchasing Controls as it related to 21CFR820.
• Risk Management experience (ISO 14971:2012).
• Effective communication skills and working knowledge of device development and commercialization, product approval, and/or regulatory inspection experience with the medical devices.
• Proven track record of good writing skills
Preferred Experience and Skills:
• Knowledge of current GMPs for combination products.
• Regulatory Affairs experience is desired.
• Strong understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (QDP); and project management principles is desirable.
• Experience in the use of root cause analysis and applied statistical techniques.
• Self-motivated and work independently
• Strong project management skills
• Proven track record of applying analytic skills in the product design, development and evaluation
• 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 and organizational skills.
• Willing to travel.
• Able to quickly pick up advanced domain knowledge.
• Able to multi-task continuously.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.
If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to email@example.com.
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Job: Preclinical Dev Generic
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Hazardous Materials: no
Company Trade Name: Merck
Nearest Major Market: New York City
Nearest Secondary Market: Newark