Johnson & Johnson is currently seeking a Process Engineering Manager to join the Heart Recovery team, based in Danvers, MA.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

• Mentor, coach and develop skills of direct reports including planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
• Mentor in areas of engineering expertise; be an agent of change; constantly moving the team towards improvements in technical skills and systems knowledge.
• Anticipate potential issues before they arise by relying on prior experience and gaining new industry knowledge.
• Qualify, optimize, and trend processes via IQ/OQ/PQ, Gage R&R Studies, Process Capability Studies, Designs of Experiments and Statistical Process Controls.
• Establish and maintain key metrics including, but not limited to yield, Touch Time, SPC, Cpk, and product quality.
• Suggest and lead technical improvements projects, estimating resource requirements, return on investments and time to implement.
• Manage resources for production floor support and production transfer efforts through recurring meeting coordination/attendance and international travel (10-25% required) between facilities, ensuring corporate objectives are met in a timely manner.
• Use Lean and Six Sigma tools to analyze process trend data or communication issues based upon data driven approach. Must identify opportunities for process and yield improvement projects
• Support and enforce company goals and objectives, policies and procedures, Good Manufacturing Practices, Good Documentation Practices, FDA QSR and ISO regulations. Intimate knowledge of FDA QSR and ISO regulations required.
• Lead team that is responsible for developing and maintaining process documentation including assembly procedures, test procedures, routers, travelers, BOMs, process flows and process FMEAs.
• Plan and schedule projects, estimating required timing, resources and budgets which are consistent with corporate objectives.
• Mentor team members in the investigation of failures and formulation and implementation of action plans for all internal corrective actions, audit findings. Address WIP and Incoming MRB in a timely manner.
• Maintain current knowledge of medical, technical, and biomedical developments as related to Abiomed products.

• BS in engineering, MBA or MS and 10 years of related work experience desired. Medical device experience preferred
• Intimate knowledge of FDA QSR and ISO regulations required
• Knowledge of lean, six sigma, kaizen, and continuous improvement initiatives. Black Belt preferred
• Ability to communicate ideas and information clearly, effectively and frequently (oral or written) within the internal project team
• Ability to exercise judgement in selecting methods, techniques, and evaluation criteria for obtaining results.
• International travel 10%-25% required
• Must be proficient in Microsoft Office Suite, Working knowledge of SAP desired.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

• This position is eligible to participate in the Company's long-term incentive program.

• Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

• Holiday pay, including Floating Holidays - up to 13 days per calendar year

• Work, Personal and Family Time - up to 40 hours per calendar year