Director, Engineering Medical Devices Job

Director, Engineering Medical Devices-PAC000195

Description

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.


The Director, Engineering (the Director) is a key technical leader within Global Technical Operations – Packaging Technical Operations (GTO - PTO). Under general scientific and administrative direction, the Director leverages experience gained on scientific, technical and business issues, to provide post-launch support for Medical Devices and Device Constituent Parts of Combination Products.

The Director leads or integrates into cross-functional, cross-divisional and cross-company teams engaged in problem-solving, change management, continuous improvement, and other assignments and initiatives. The Director must demonstrate advanced knowledge, skills and abilities to create and optimize business, technical and compliance processes. She/ he frequently leads or enables high impact teams, to plan and execute complex projects and initiatives in very short timeframes. She/ he provides Project leadership/ support for device design changes, tooling qualification, life-cycle management of manufacturing and test equipment, and material and process changes. She/ he provides on-site, hands-on direction to External Partners engaged in device/ component manufacture, assembly and testing, including creation of test plans for Design of Experiments and process validation. She/ he develops protocols and reports, performs process capability assessments, and establishes methods to control process output.

The Director is an expert at PFMEA, and is a key enabler in the support of Risk Assessment and mitigation activities. She/ he plays an important role in ensuring that the division’s Key Performance Indicators are met, including supply, compliance and safety.

The Director is an expert in medical device manufacturing, including precision injection molding, assembly, performance testing, Fill – Finish, and the accompanying major market regulations (existing and emerging) for Design Controls. She/ he will develop and execute strategies to improve robust supply of devices and device constituent parts, and will be a key leader in providing Rapid Response support to resolve issues in a compliant, fast-paced manufacturing environment.

The Director, Engineering applies Science with a Business Focus:

- Understands the criticality of securing early sponsorship and stakeholder alignment on projects and initiatives;

- Sees the big picture, and how activities link to strategy and business outcome;

- Operates effectively as a leader in assigned roles on projects, or as GTO – PTO representative on multiple teams;

- Displays ownership and makes informed cost/ benefit decisions based on analysis of inputs, outcomes, risks and likely returns;

- Practices the necessary Inclusive Behaviors to integrate inputs and perspectives from various sources;

- Continuously undertakes professional development activities to improve skills.

- Utilizes packaging expertise to develop value-add solutions to customer needs in packaging and medical devices.

- Solicits inputs to ensure customer/ patient/ stakeholder needs are at the core of his/ her decisions.

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

- Deploys expert knowledge and proficiency in packaging, to enable multiple/ complex supply chain nodes associated with manufacturing, logistics and distribution.

This engineer demonstrates the appropriate culture in interactions with others.

- Actively supports and applies various initiatives and goals of MMD and the company..

- Acts as a catalyst for change.

- Facilitates reassignment of roles and responsibilities across teams to facilitate goal achievement and team development.

- Contributes to developing technical skills in organization.

- Speaks and presents effectively to both internal and external audiences to influence change and build consensus.

- Proactively reviews own performance and progress, and seeks stakeholder feedback to close gaps.

- Provides candid, timely and tactful communication and feedback to teams and collaborators.

- Mentors and coaches less experienced engineers to develop talent.

- Builds and maintains strong relationships and partnerships with key internal stakeholder functions, and with External Partners.

Qualifications

Education:

- Technical BS degree or higher (PhD). Preferred Chemical Engineering, Packaging Science, Mechanical Engineering, Materials Science, Pharmaceutical Sciences or similar.

Required Experience:

- Experience in Medical Device manufacturing and plastic injection molding.

- Experience in Pharmaceutical major markets’ regulations, e.g. USFDA cGMPs, EMA.

- Knowledge of metrology and Acceptance Sampling as used for Quality Control.

- Knowledge of Design Control for Medical Devices

- Advanced project management skills, from conception/ initiation, through close-out.

- Competence in MS Office Suite, Minitab, Solid Works.

- Demonstrates Merck Leadership Behaviors.

- Takes an end-to-end view of the supply chain to understand upstream/ downstream impact of actions taken at any node

- Experience leading and enabling diverse teams.

- 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:

- Completes activities with the highest regard for all Merck divisional and local site procedures for safety, quality, and regulatory compliance.

- Provide technical leadership to packaging sites and functional areas, including the preparation of official documents

- Excellent oral and written communication skills

Preferred:

Green belt six sigma certification.

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 staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

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

EEOC Poster

EEOC GINA Supplement​



Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Packaging Engineering

Job Title:Dir, Engineering

Primary Location: NA-US-PA-West Point

Other Locations: NA-US-NJ-Kenilworth

Employee Status: Regular

Travel: Yes, 25 % of the Time

Number of Openings: 1

Shift (if applicable): N/A

Company Trade Name:Merck