Job Description

Job Description

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

The Associate director of medical device and combination products (MDCP) is a key technical leader within the Pharmaceutical Technical Operations team. 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 our Company'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 Operations, New Products Commercialization, Quality Operations, CMC Regulatory Affairs, and Global Procurement. and suppliers.

Knowledge of design control, medical device, combination products, material science, polymer processing, 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.

Position Responsibilities

* Understands the big picture, and how activities link to our Company strategy and business goals.

* Utilizes design control expertise to develop value-add solutions to customer needs in medical devices and combination products

* Understands the criticality of securing early sponsorship and stakeholder alignment for projects and initiatives.

* Operates effectively as a leader in assigned roles on projects, or as MDCP technical operations representative on multiple 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

* 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.

* Actively supports and applies the various initiatives and goals of our Manufacturing Division and the company.

* Ensures expectations are met on a consistent basis, and works with a long-term perspective to address customer needs.

* 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.

* Provides candid, timely and tactful communication and feedback to team and collaborators.

* Demonstrates our Company Leadership Behaviors.

Education Minimum Requirement:

* BS Degree or higher (MS or PhD)

* Preferred BS in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Polymer or plastic engineering, Pharmaceutical Sciences or similar.

Required Experience and Skills:

* 8+ years of experience in medical device, pharmaceutical or in biotech organizations.

* Significant experience in the regulations of major markets in the medical device or Pharmaceutical industry, e.g. USFDA cGMPs, EMA.

* Significant experience with medical device or combination product commercialization, operations support, and materials/components.

* Experience in plastics injection molding, and polymer processing is highly desired.

* Experience in any of the medical devices or combination products like inhalers or implants or injectable drug delivery systems

* Subject matter expert in design controls, deviation management, change control, risk management and the fundamentals of documentation structure/ systems.

* Proficiency in project management, from conception and initiation, through close-out.

* 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 our Company 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

Preferred Experience and 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

NEWCO

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.
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1
Requisition ID:OR000036C