Staff Engineer, Combination Product Development

Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.

ROLE SUMMARY

The Combination Product Development team is a dynamic, growing part of Kindeva’s Development Services organization. We have recently opened a facility in Germantown, MD and are seeking talented team members to help us provide customers in each major drug delivery combination product segment with a comprehensive offering of market-ready combination product platforms and world-class development service capabilities throughout the product lifecycle.

As the Staff Engineer, Combination Product Development, you will drive development of certain new drug delivery devices including autoinjectors. You will report to the Senior Director, Combination Product Development, and will provide technical leadership and subject matter expertise for combination products, specifically autoinjectors and/or alternative drug delivery devices.

This role is both strategic and hands-on in nature. You must have product development experience to be successful in this role. Combination product development experience is desired.

This role will lead all development aspects including engineering, design, optimization, robustness, reliability for assigned projects. You will lead thorough debugging, and smooth design transfer. A highly desirable plus is to bring Design for 6 Sigma/CPDM expertise to the role. Because we support product development for external clients, this role needs to have strong communication skills with the ability to communicate technical information to both technical and non-technical audiences. In addition to engineering support for new product development projects, this role will be responsible for managing and overseeing our engineering lab. The role will support engineering lab activities including, but not limited to, managing calibrations, test method development and validation, lab-scale assembly process development, inventory management, rapid prototyping, design control documentation and general lab maintenance. This is a hands-on role, as we are a growing organization, and the ability to work independently and as part of a team will be critical.

This is a unique opportunity to have a direct impact on delivering final product solutions to our partners, patients, and will have direct impact on the overall success of the organization.

We are building a culture of individuals who embody our PRECISE Values and expect you to lead with personal responsibility, respect, excellence, transparency, innovation, commitment, and energy.

BASIC QUALIFICATIONS

• A minimum of 7 years of pharmaceutical, device and/or diagnostics development
• BS required, MS preferred in engineering or relevant technical discipline including but not limited to biomedical engineering, mechanical engineering, or chemical/biochemical engineering.
• Product development experience in regulated industry.
• Able to apply engineering skills and practices to gather user requirements and translate them into technical studies/assessments for drug delivery systems for characterization or qualification.
• Effective self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of a GMP environment.
• Ability to work on-site in Germantown, MD
• Ability to do domestic and some international travel [up to 25%].

PREFERRED QUALIFICATIONS

• Experience in the development of autoinjectors, pre-filled syringes, or other combination drug delivery devices is required.
• Experience with Combination Product regulations, analytical chemistry and experience with auto injector design/function is required.
• Relevant combination product verification and validation experience utilizing global quality and regulatory standards such as 21 CFR 820, ISO 9000,13485 and 14971. Strong knowledge of prefilled syringe and autoinjector technical standards (e.g., ISO 13485, ISO 11608, ISO 14971) is required.
• Experience developing drug delivery devices for emergency use
• Experience developing drug delivery devices for military and/or first responder applications
• Expertise in Design for Six Sigma and Critical Parameter Development & Management methodologies
• Experience in the development of autoinjectors, pre-filled syringes, or other combination drug delivery devices is required.
• Experience with Combination Product regulations, analytical chemistry and experience with auto injector design/function is required.
• Relevant combination product verification and validation experience utilizing global quality and regulatory standards such as 21 CFR 820, ISO 9000,13485 and 14971. Strong knowledge of prefilled syringe and autoinjector technical standards (e.g., ISO 13485, ISO 11608, ISO 14971) is required.

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