POSITION SUMMARY:

The Senior Director Engineering will be responsible for establishing, leading, and managing the operations engineering team for regulated products including process validation, product cybersecurity, and metrology. This position will ensure that the Archer provides its internal and external customers with industry leading and innovative products and services that meet or exceeds established requirements including US FDA regulations, GMP (good manufacturing practice) and ISO 13485:2016.

RESPONSIBILITIES:

• Establish the direction and strategic goals for the global regulated products engineering department.
• Oversee day to day operational aspects of engineering as it to relates to process improvements for process, equipment and environmental validation and product cybersecurity to ensure compliance and optimization.
• Identify and diagnose opportunities for improvement that impact safety, environment, labor productivity, machine/manufacturing efficiency, cost reduction, product quality and other key performance objectives as defined by the business and work in concert with cross functional department heads to define and execute improvement plans.
• Anticipate operational problems by studying operational targets, modes of operation, and unit limitations by collecting, analyzing and summarizing operating, engineering and quality data and trends and coordinate with cross functional teams to mitigate risk.
• Collaborate with project management to ensure effective resource utilization, planning, and execution of projects that are in alignment with business objectives.
• Develop, monitor and report on KPI’s related to engineering to the executive management team.
• Develop department goals and annual budget and achieve results within budget and on schedule.
• Guide staff in preparing and managing implementation of plans related to validation of process, equipment and/or environments, product cybersecurity, and metrology while developing approaches and strategies in alignment with internal procedures and industry best practices.
• Recruit, direct, coach and develop staff to maintain a high level of technical expertise that works collaboratively with key partners.
• Review personnel performance and compensation. Responsible for all hiring decisions within the team, including obtaining new position approvals.
• Build and maintain positive and collaborative relationships cross-functionally with management, peers, subordinates, and externally with third party suppliers, contract organizations, and regulatory authorities.
• Responsible for driving continual people, process, and product development and improvement throughout the organization ensuring product integrity.
• Promote quality culture throughout Archer, ensuring compliance to policies, procedures, and regulations sustained through reinforcement of quality at all levels.
• Lead by example to create an inclusive culture that values high engagement.
• Perform other duties as assigned by manager.

KEY ATTRIBUTES:

• Passion for enhancing healthcare outcomes with novel technology.
• Exemplify the Company Values: Accountability, Care, Trust, Grit and Urgency.
• Inspirational people leader with a history of managing teams to deliver their best work.
• Strategic thinking combined with systems planning.
• Strong organizational capabilities need to scale.
• History of thriving in a fast-paced, dynamic environment.

EXPERINCE:

• Minimum of 10 years in a leadership position.
• Experience developing a scalable efficient compliant organization.
• History of integrating processes in medical device manufacturing and maintenance.
• Working knowledge of cGMP/CFR/FDA regulations and ISO standards.

EDUCATION:

• Bachelor's degree required; Master’s Degree preferred