Archived listing. The details below describe a past opening.
Description
Scope of Position:
In this role, you will report directly to the Chief Business Officer and lead the front-end development of manufacturing opportunities for customers developing consumable medical devices. This role is responsible for managing a team across multiple projects to determine whether a customer’s device is manufacturable, whether there is a meaningful market opportunity for the product, and whether the product and customer are ready to move toward manufacturing. You will lead a team of 3 FTEs and up to 1-2 interns/co-ops. Some travel (approx. 10-20 days/year) will be required for this position to attend conferences, trade shows, and meet with customers and network partners.
Success in this role is defined by preparing and advancing opportunities to the point where they can be confidently handed off to Drummond’s engineering and operations teams, which are responsible for designing, building, and operating the manufacturing lines required to produce the customer’s product at scale.
Key Measure of Success:
The primary measure of success for this role is the ability to identify, qualify, and advance manufacturing opportunities to the point where they can be successfully handed off to Drummond’s engineering and operations teams. A successful handoff means the product is understood, the manufacturing opportunity is commercially meaningful, the device is ready for manufacturing development, key technical and regulatory requirements have been identified, and the downstream teams have the information needed to design, build, validate, and operate the manufacturing lines required to make the customer’s product at scale. This role will also be responsible for developing, maintaining, and regularly reporting key performance indicators that measure opportunity quality, development progress, readiness for handoff, customer engagement, risk reduction, and conversion of qualified opportunities into executable manufacturing programs.
Primary Responsibilities:
- Lead the front-end development of manufacturing opportunities for consumable medical devices, from customer concept and early technical evaluation through readiness for handoff to engineering and operations.
- Assess whether customer products are manufacturable at commercial scale, including evaluation of device design, materials, tolerances, assembly approach, quality requirements, clean room needs, sterilization considerations, packaging, shipping, and regulatory expectations.
- Evaluate the market and commercial opportunity for prospective manufacturing programs, helping determine whether the product, customer, and business case justify investment in scalable manufacturing development.
- Partner with customers and OEMs to translate product concepts into clear manufacturing opportunity definitions, including technical requirements, commercial assumptions, development risks, and readiness milestones.
- Develop the technical and commercial package needed to transition qualified manufacturing opportunities to Drummond’s engineering and operations teams for manufacturing line design, build-out, validation, and operation.
- Serve as a technical and commercial bridge between a customer’s device concept and Drummond’s downstream engineering and operations execution, ensuring opportunities are well-defined, manufacturable, commercially viable, and ready for scale-up.
- Develop, track, and report key performance indicators on a regular basis to communicate the status, quality, risks, readiness, and conversion of manufacturing opportunities across the development pipeline.
Requirements
Requirements:
- Demonstrated experience bringing a consumable medical device from concept through commercialization, preferably in IVD, IVF, diagnostics, life sciences, or a related MedTech market.
- Strong scientific and/or engineering background with the ability to understand the mechanics, materials, tolerances, assembly methods, and performance requirements of physical medical device components.
- Experience developing or reviewing design history file inputs, design requirements for manufacturing, process requirements, validation plans, and commercialization documentation for medical devices.
- Working knowledge of requirements that affect manufacturability and commercial launch, including sterilization, clean room manufacturing, packaging, shipping, quality system, and regulatory considerations.
- Proven ability to design, scale, or lead manufacturing processes for high-volume production of consumable devices or comparable precision components.
- Ability to qualify and structure manufacturing opportunities before handoff to engineering and operations, including defining manufacturability requirements, customer readiness, technical risks, commercial assumptions, and scale-up needs.
- Strong communication, influencing, and project management skills, including the ability to translate technical manufacturing requirements into clear customer and internal execution plans.
- Minimum ~7 years of professional experience in project management respecting medical device manufacturing, manufacturing development, process engineering, product development, or a related field.