Associate Director, Medical Device and Combination Products Job - United States
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. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Associate director of medical device and combination products (MDCP) is a key technical leader within GTO Packaging Technology. Under general scientific and administrative direction, the engineer leverages experience gained on scientific/technical/business issues to support project teams and other technical staff. The engineer must demonstrate advanced knowledge, skills and abilities to create and optimize business, technical, and compliance processes. The person in this position participates in high impact, complex, cross-functional and cross-divisional teams and initiatives, and will provide significant leadership to achieve project goals. Effective collaboration with teams is essential to meet Merck's goals/objectives.
This engineer will support complex global and site projects, including those related to Combination Products and Drug Delivery Systems, in a compliant manner.This includes leading, enabling or consulting in the development and execution of related strategic plans for problem-solving and continuous improvement by working with internal and external partners. Key interfaces include sites, External manufacturing, Quality Ops, Product Development groups, Regulatory Affairs, Procurement and suppliers.
Knowledge of design control, medical device, combination products, pharmaceutical packaging and related scientific/technical concepts and techniques are highly desirable for this position. The ability to apply these in a fast-paced operating environment to resolve issues and meet customer needs in a compliant manner are at the core of this position. The engineer will routinely face competing priorities, and must manage time effectively, while keeping stake-holders and team members informed with effective communication.
- Understands the criticality of securing early sponsorship and stakeholder alignment for projects and initiatives.
- Understands the big picture, and how activities link to Merck strategy and business goals.
- Operates effectively as a leader in assigned roles on projects, or as PTO representative on multiple small teams.
- Displays ownership and makes informed cost/ benefit decisions based on analysis of inputs, outcomes, risks and likely return.
- Demonstrates the necessary Inclusion skills to integrate inputs and perspectives from various sources, and communicates the decision and its Risk/Benefit implications to key stakeholders and sponsors.
- Continuously undertakes professional development activities to improve skills
- Utilizes engineering expertise to develop value-add solutions to customer needs.
- Solicits feedback to ensure that customer/stakeholder needs are the cornerstone of his/her decisions, expectations are met on a consistent basis, and works with a long-term perspective in addressing customer problems.
- This engineer demonstrates the appropriate Culture in interactions with others
- Actively supports and applies the various initiatives and goals of MMD and the company.
- Ensures expectations are met on a consistent basis, and works with a long-term perspective to address customer needs.
- Utilizes design control expertise to develop value-add solutions to customer needs in medical devices and combination products
- Acts as a catalyst for change
- Facilitates the re-allocation of roles and responsibilities across team members to facilitate goal achievement and personal development.
- Contributes to developing technical skills in organization and builds high performance teams.
- Speaks/presents effectively to both internal and external audiences to influence change and build consensus.
- Continually improves communication systems and practices within and across teams/units/functions.
- Proactively reviews own performance and progress, and seek feedback from manager/peers/stakeholder to close gaps.
- Provides candid, timely and tactful communication and feedback to team and collaborators.
- Utilizes engineering expertise to develop value-add solutions to customer needs in medical devices and packaging
- Technical BS degree or higher (MS or PhD)
- BS in Mechanical Engineering, chemical engineering, biomedical engineering, materials engineering, pharmaceutical Sciences or similar.
- A minimum of 8 years of experience in medical device, pharmaceutical or in biotech organizations.
- Significant experience in the regulations of major markets in the Pharmaceutical industry, e.g. USFDA cGMPs, EMA.
- Significant experience with medical device or combination product commercialization, operations support, and materials/components.
- Experience using quantitative decision tools for Risk Management and options analysis.
- Subject matter expert in design controls, deviation management, change control, and the fundamentals of documentation structure/ systems.
- Proficiency in project management, from conception and initiation, through close-out.
- Demonstrates Merck Leadership Behaviors.
- Experience leading and enabling diverse teams.
- Takes an end-to-end view of the supply chain to understand upstream/ downstream impact of actions taken at any node.
- The engineer applies the following competencies in a manner that challenges and enhances overall operational effectiveness and routinely provides feedback and coaching to team members and collaborators on these skills
- Completing all activities with the highest regard for all Merck divisional and local site procedures for safety, quality, and regulatory compliance.
- Provide technical leadership to medical device and combination product manufacturing sites and functional areas, including the preparation of official documents
- Excellent oral and written communication skills
- Experience in design control, risk analysis and change control management for medical device or combination products
- Knowledge of sterile and non-sterile combination products.
- Experience with Drug Delivery Systems is highly desirable.
- Lean Six Sigma Green Belt or higher certification
- Experience in plastics injection molding, and polymer processing is highly desirable.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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Job: Packaging Engineering
Job Title:Assoc. Dir, Engineering
Primary Location: NA-US-PA-West Point
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Medical, Manager, Engineer, Biotech, Chemical Engineer, Healthcare, Management, Engineering, Science