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Job Description:

Purpose:

This role will execute engineering deliverables in support of large-scale manufacturing capacity projects that will yield stable, reliable and cost-effective manufacturing process meeting projects FPO’s of capacity, product cost, budget and timeline.

The scope of this position will include both project delivery as well as ensuring knowledge transfer from developing manufacturing site staff and will work in collaboration with the existing DPS functional organizations to ensure standardization and the implementation of Best-in-Class practices.

This position supports the Orthopedics platform within J&J MedTech in manufacturing orthopedic implants used in knee, hip and shoulder joint arthroplasty.

You will be responsible for:

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Supervises engineering staff in execution of project deliverables
• Provides oversight of work, mentorship and coaching to engineering staff to develop technical proficiency and assure delivery across the team
• Supporting delivery of robust and fully developed and qualified orthopedic implant manufacturing processes to Network Edge projects
• Ensure that all project activities are conducted in line with procedures and controls outlined in the QMS and that the quality and performance of the product conforms to specified standards and in compliance with the recognized Regulatory Standards for relevant markets.
• Collaborate with functional stakeholders to ensure that technical, validation and regulatory strategies are implemented in an efficient and compliant manner and at an appropriate risk level
• Partner with Regulatory to execute the strategy necessary for all filings, inspections, and registrations in multiple sites and countries.
• Communicates with internal and external partners to coordinate and execute project plans.
• Provides technical leadership and supports execution of EHS&S policies and procedures
• Supporting technical collaboration across functions
• Leads effective and timely communication processes and stakeholder management processes within the project scope and ensures project and program activities are consistently documented.
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed.

Qualifications / Requirements:

EXPERIENCE AND EDUCATION

• University/Bachelors Degree or Equivalent.
• Experienced knowledge of medical device manufacturing and validation.
• Minimum four (5) years of relevant professional work experience.
• Ability to communicate effectively in English and Spanish across functions and both internally/externally.
• Ability to perform duties in accordance with policies and procedures and in to comply civil rights requirements.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES

• Statistical and problem-solving engineering expertise (Six Sigma, SE or A3)
• Strong interpersonal and communication skills & demonstrated ability to operate as part of a team.
• Track record of innovation and adaptability in project execution, with strong problem-solving skills.
• Proven competence to evaluate communicate and act upon significant risks, demonstrating leadership of the high standards of quality and compliance.
• Strong influencing skills - Excellent interpersonal skills (written and oral).
• Decision Making – Required to make decisions on technical and management issues.
• Direct experience in manufacturing of high precision machined products within a highly regulated environment.
• Experience with validation IQ/OQ/PQ and risk management documentation.

Required Skills:

Preferred Skills: