Our client a medical device start up currently seeks an Operations Manager to join their team. The Operations Manager is a key role and will be a member of the senior leadership team. This is a new role and reports directly to and works with the Company CEO to develop, build out and manage the Company’s Operations Function. The Operations Manager is responsible for managing the outsourced manufacturing and supply chain activities of the Company. This includes but is not limited to transfer from R&D to production, component management, supplier and partner management, inventory and supply chain management, COGS optimisation and transfer from manufacturing to customer sites based on sales order requirements. The Company plans to grow and develop over the next number of years. The Operations Manager will over time build a strong operations team from the ground-up in accordance with Company plans. They will hire and oversee a growing Operations team and ensure they are properly resourced and developed to achieve company targets.
Set up, lead and develop the Company’s Operations, manage inventory and production to ensure products are manufactured and delivered to market on time and in line with forecasts & orders, in the most efficient manner possible.
Lead the Company's outsourced manufacturing activities to ensure maximum effectiveness is achieved in the production of high-quality products in a timely and cost effective manner
Accountable to ensure products meet or exceed expected quality standards and any applicable regulatory requirements
Manage all aspects of capacity planning, manufacturing & product delivery
Manage new product qualification, introduction and ramp-up to high volume supply
Manage and drive Supply & Logistics partners to achieve delivery and COGS to set targets, whilst at all times maintaining the appropriate quality standards.
Propose, negotiate with and qualify new suppliers for existing and new/future products.
Propose, prepare and execute initiatives to constantly improve production capability, quality, cost-reduction, inventory management and customer service goals.
Manage global logistics including maintaining a positive relationship with all partners while at the same time driving costs, timelines and standards.
Ensure that all manufacturing activities are in compliance with quality and regulatory requirements.
Manage and supervise new R&D products transition to manufacturing.
Maintain a close relationship with R&D with a particular focus around ensuring that COGS and manufacturability feedback is incorporated into new product design.
Working with the external supply, manufacturing and logistics partners, achieve operational excellence in terms of cost, supply, quality, and yield.
Understand the Company’s market and sales process to ensure that there is a smooth and transparent relationship between Operations and the Sales Organisation.
Integrate with and participate in cross-functional teams bringing Operations expertise to bear across the Company.
Masters or Bachelor’s Degree (level 8) in Science, Engineering, or similar technical discipline.
8+ years Operations Management experience, with proven track record in a regulated manufacturing / operations environment.
Deep knowledge of ISO13485 standards and EU/FDA regulatory environments.
Excellent interpersonal and communication skills.
Track record in people motivation, organisation development and team building experience, ideally in start-up environment.
Proven relationship building & management experience, including effective stakeholder management expertise.
Solid strategic planning abilities and good business acumen.
Track record in leading projects to a successful completion.
Proven track record in successfully launching new products and managing projects.
Prior experience at a senior level managing an Operations function in the Medtech industry.
Experienced in managing an outsourced Medtech manufacturing provider or alternately managing the provision of outsourced manufacturing services to Medtech companies.
Experience of successfully launching new products to manufacturing in the life sciences industry.
Successful in managing and developing relationships with Partners whilst obtaining required results in a supply chain environment.
Experience of managing people and ensuring that all team members are trained, motivated and performing highly on a consistent basis.
Highly motivated individual with a strong work ethic, ambition with technical and soft skills to deliver on talent.
Have a significant interest in user needs, product development, and the process of bringing solutions to market.
Excellent communication skills that can harness and develop internal and external engagement.
Deep interest in bringing innovative medical products to market to fulfil patient needs.
Ability to fit into a close-knit team with a highly collaborative culture and can-do attitude.
For more information contact James Cassidy at firstname.lastname@example.org or call in confidence 0860204322