Position Overview: (Medical Device Start Up) The COO will play a major role in the company’s executive management, by working with the CEO and CSO to manage tasks and systems necessary for first product launch. This individual will work closely with other members of our team developing, integrating and resolving the inevitable bumps in the road of product development.
Roles & Responsibilities
- Oversee ongoing and future business operations; oversee strategic planning, development and coordination of all operations
- Provide leadership, supervision, mentoring, and development of department managers and support staff in the following areas: Manufacturing, Sustaining Engineering, Supply Chain, and Corporate Finance.
- Work closely with management to plan and achieve the current and long-term strategic objectives. Apply strong operations management techniques and implement long-term business improvements through strategic thinking and positioning.
- Develop and maintain annual and future manufacturing plans that support the Company’s overall long-term strategic plan. Focus on understanding future needs for manufacturing processes, technology, and capacity. Anticipate future obstacles, generate and implement strategic plans to align with Company goals.
- Develop and maintains high level corporate relationships with suppliers, including setting terms, negotiating large cost items and dispute resolution
- Maintain front-line responsibility for operating efficiency and excellence. Manage, improve, and achieve operating profitability as part of manufacturing operations. Use a data and results focused approach to managing daily operations.
- Participate in the development and preparation of short-term and long-range plans and budgets based upon broad organization goals and objectives
- Works with partners during project transfer, facilities audits and operational reviews
- Appraise and evaluate the results of overall operations regularly and systematically, and report these results to the CEO
- Ensure that all activities and operations are performed in compliance with local, state, and federal regulations and laws governing business operations
- Collaborate with management to support new product development efforts from a manufacturing and sustaining engineering perspective.
Qualifications & Skills
- Able to lead multiple complicated and intense projects
- Comfortable with fast-paced and irregular work native to early-stage start-ups
- Must be a proactive problem solver and a great manager
- Excellent written and verbal communication skills and people skills
- Able to negotiate and manage deals
- Capable of delegating well and effectively monitoring the progress of team members
- Strong analytic skills; uses data to monitor organizational progress, make decisions and predict possible future outcomes
- Resourceful and creative; exhausts networks and partnerships to explore all options
Experience
- Medical Device Experience – Experience working with medical device companies and/or other regulated product companies (biotech, pharma,)
- Direct Manufacturing Management Experience – Ability independently develop and/or manage the development and implementation of manufacturing specifications, vendor and parts qualifications, product and facilities inspections, product testing and lean activities with cGMP, ISO and customer-imposed requirements
- Manufacturing Management Experience – Ability independently develop and/or manage the development and implementation of manufacturing processes, specifications, resource planning, capital equipment procurement and maintenance, and electro-mechanical product assembly in compliance with cGMP, ISO and customer-imposed requirements
- Supplier and Production Management Experience – Experience leading supplier management activities, including sourcing, supplier assessment, production planning and management; negotiations and issues resolution; logistics planning, and management
