ABOUT THIS JOB
Location: Virginia Beach, VA (on-site)

Department: Tissue Engineering

Schedule: Full-Time, Monday - Friday, 8:15 a.m. - 5:00 p.m. (ET)

Clinical Status: Clinical

HOW YOU'LL MAKE AN IMPACT
The Manager, Process Engineering is responsible for management of tissue process design, validation, implementation and improvements in accordance with applicable regulatory requirements. Ensure all activities are compliant with FDA regulations, ISO regulations, and AATB standards. Provides leadership and mentoring to the Engineering staff. This position will require strong analytical skills and a systems approach to problem solving. They must embrace Lean concepts, drive continuous improvements, commit to regular reduction of costs, and ensure the development of lean systems and procedures.

Your work will have purpose every single day, contributing directly to life-changing outcomes.

WHAT YOU'LL DO

• Team Leadership & Talent Development: Provides leadership to assigned team by leading, guiding, and directing employees to be effective team members. Ensures staff are equipped with the skills, tools, and talents necessary to perform their duties. Utilizes established people processes (performance, development, succession, and career) to ensure team capabilities meet current and future organizational needs.
• Process Transfer & Validation Oversight: Leads teams to execute the transfer of new processes and products from Product Development to Production and Logistics. Ensures effective technical training of production staff. Develops, reviews, provides feedback on, and approves process validation protocols in alignment with regulatory principles.
• Project & Continuous Improvement Leadership: Leads staff in executing projects of varying scope and complexity, including multi-department initiatives focused on process and equipment improvement. Ensures alignment with LifeNet Health standards and applicable regulatory requirements.
• Operational Management: Monitors and reports key performance indicators and objectives to support continuous improvement and timely completion of tasks and projects. Contributes to department goal-setting and maintains costs within approved budgets. Writes and revises material and equipment specifications. Develops and updates SOPs and Work Instructions as required.

WHAT YOU'LL BRING
Minimum Requirements:

• Bachelor's degree in Engineering or a related technical field
• Five (5) years of relevant Engineering experience
• Three (3) years of progressively responsible leadership and management experience with demonstrated success in a highly complex organization.
• Three (3) years of project management experience within a regulated environment.

Preferred Experience/Skills/Certifications:

• Bachelor's degree in Engineering
• Master's degree in Engineering or Business Management
• Three (3) years of Process Engineering experience in Medical Device, Pharmaceutical, or Biomanufacturing industries.
• Certified Associate in Project Management (CAPM) or Project Management Professional (PMP)

Key Knowledge, Skills, & Abilities:

• People Development: Actively engages in talent management practices (selection, promotion, development, and engagement) to cultivate a workforce that is well aligned with current and emerging talent needs.
• Relationship Management: Builds and sustains partnerships across organizational boundaries and functions as well as outside the organization to achieve common goals and outcomes.
• Communication Skills: Written, verbal and presentation; ability to engage, inspire and influence people.
• Microsoft Office: Proficient in Microsoft Office and in Project Management Software (e.g., MS Project).
• Organizational Skills: Ability to plan, implement and monitor assignments effectively to meet the needs of the business.
• Time Management: Ability to use time in an effective and productive manner with ability to work under pressure with tight timelines, make critical decisions and maintain a sense of focus and urgency.
• Analytical Thinking: Demonstrates the ability to successfully gather and evaluate pertinent information to draw conclusions and identify potential trends.

COMPENSATION

Salary Range: $115,356 - $153,808 annually

Final compensation will be based on factors such as geographic location, qualifications, and prior relevant experience. The pay range for this position is $115,356 annually (entry level qualifications) to $153,808 annually (experienced in this role). Actual compensation may be higher based on the successful candidate's knowledge and relevant experience.