Director, Technical Engineering Operations

Position Summary/ Objectives

The Director, Technical Engineering Operations is responsible for operational product science, from scale-up through sustaining and end of life cycle, including, process qualifications and after-market product support (sustaining). The role encompasses engineering and collagen science disciplines. The Director, Technical Engineering Operations is responsible for directing the efforts of the Integration and Sustaining teams (including individual contributors within the broader technical & engineering group).

The goal of the role is to assure scientific integrity of product design execution from the point of transfer from R&D to production operations (integration) through product to end of life cycle. The Technical Director, Engineering Operations will direct the efforts of a team of specialist engineers and scientists with a dual emphasis on; smart, effective, execution of programs in partnership with Project Management Office (PMO), with R&D and Operations; and, execution of sustaining activities in partnership with Operations (Manufacturing, Supply chain) and Quality teams.

The incumbent will lead these teams and individuals to define and achieve the goals required to complete work on time and within budget. The role is dependent on successful, collaborative, cross-team working within the Operations team and with other functions (Commercial, R&D, Quality, for example). The Technical Director will communicate clearly and effectively with Executive Leadership Team, stakeholders, customers, and, functional technical resources. The successful candidate will have proven effectiveness in use of metrics and dashboards to assimilate and communicate complex data sets and will possess highly developed interpersonal skills, technical ability in our industry, team leadership and management capability, and, confidentiality.

Essential Job Functions:

• Direct the work of the Integration team to effectively execute on design transfer and scale up activities including process qualifications and transfer to Manufacturing and Supply Chain operations. Communicate the status of ongoing efforts.
• Direct the work of the Sustaining team, in partnership with Facilities Engineering and Quality to help ensure compliant, effective, post launch processes and products, for example through CAPA task execution and yield improvement or other cost optimization project work. Communicate status and challenges across functions.
• Establish effective working relationships with internal and external activity stakeholders with strong emphasis on clear and effective communication.
• Ensure that all appropriate technical documentation, drawings, specifications are generated in compliance with Regenity procedures, statutory requirements (e.g. US FDA, notified bodies) and/or applicable standards.
• Using a metrics-based approach, including use of dashboards or other visual tools, routinely update company leadership on progress and challenges being encountered. Present recommendations for action where challenges occur.
• Monitor project and ongoing work performance, measure timeliness and future risk, and, provide guidance to project resources. Escalate issues, or, otherwise support resources experiencing challenges to proactively assure successful outcomes.
• Develop relationships with key customers to understand and resolve technical issues arising during new product introduction and scale-up.

Competencies:

1. Meaningful Innovation
2. Ownership/Accountability
3. Pace/Efficiency
4. Teamwork/Collaboration
5. Integrity/Ethical Practice
6. Resilience/Grit

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 50 pounds.

Supervisory Responsibilities:

This position manages program leadership to ensure projects achieve desired outcomes

Education, Experience, and Certification:

• Master’s Degree in a scientific or engineering discipline, including an academic component where collagen and/or tissue science is strongly preferred.
• 10 years of experience in the medical device industry.
• 5 years of experience in senior* decision making role, working with collagen products
• Excellent interpersonal skills in addition to having the ability to effectively communicate within the technical teams as well as to top level management
• *Decisions are of material impact to the business in respect of product quality, cost or service.
• Collaborative leader who excels in leading through ambiguity
• Ability and experience with communicating effectively with executive leaders.
• MS Project software experience
• Understanding ISO and FDA guidelines as they apply to operational quality, GMP, validation
• Excellent organization and time management/multi-tasking skills
• Thrives in an ambiguous and fast-paced environment, operating at both strategic and tactical levels

Other Duties as Required:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.