SR. Manager Device & Drug Delivery Systems (Engineer)

The SR Manager Device & Drug Delivery Systems (Engineer) This is an individual contributor position and this person will be the technical expert in the field of combination products & drug delivery devices who can effectively navigate and balance complex engineering, regulatory, quality and commercial needs while developing the best product for the user and patient. Primary expertise should be demonstrated in engineering, device regulatory, device quality systems (CFR 820, ISO 13485), human factors engineering principals, risk management for medical devices (ISO 14971), etc. The successful candidate should demonstrate strong technical writing and presentation skills and be able to translate technical information to non-technical audiences. This position requires 7 - 10 years of applicable experience in the pharmaceutical, biotechnology or medical device industries.

The candidate will be responsible for the creation and management of design history files and technical dossiers for combination and device projects for new and existing products. Additional responsibilities include facilitation of risk assessments, coordination of human factors usability studies, creation and management of product and component specifications, design control documents, engineering protocols and reports and frequent presentations to project teams and management. This position will frequently require management of outside resources as well as assigned and/or unassigned leadership of project teams in a matrix organization. Technical Writing experience required.

The position may involve frequent domestic and international travel up to 10% or as required by the project. Will manage indirect reports.

Support the vision for the Device Development function

• Support and implement a vision with appropriate strategies that supports the OPDC objectives and aligns with the business and OPCJ/OPDC/MDD development programs
• Work with members of Device Development and Technology, and other functions including Packaging, Supply Chain, Clinical Supplies Operations, Quality Control, Regulatory and Quality Management to support strategies for product and process improvements
• Support the development of flexible and compliant product development process.

Develop and support the strategic activities of the department:

• Support and implement appropriate filing strategies working with OPCJ, OPDC, MDD and OAPI departments to support registration of all new products and life-cycle management products.
• Initiate and manage the development and implementation of policies, procedures, and standards for the Device Technology department.
• Evaluate and recommend strategic directions for new and innovative delivery device technologies to support new and life-cycle management projects.

Develop and perform the tactical activities:

• Ensure efficient transfer of products and on-going product support all products to CMOs from device perspective.
• Develop and maintain departmental knowledge, experience, and expertise in state-of-the-art devices for pharmaceutical products.
• Assure adherence to latest worldwide regulatory rules and guidance concerning devices and work to develop device risk mitigation.
• Create, maintain and update device related documents required for regulatory filings and compliance
• Facilitate studies as required.

Program management of Device projects:

• Develop project plans and corresponding project managements tools to support the execution of all projects
• Manage cross functional teams (including 3rd party resources)
• Execute Human Factors Engineering & Usability activities
• Write protocols, reports, specifications, procedures, change control requests, technical assessments, etc

Required:

• Bachelors degree in a related Engineering discipline (Mechanical, Electrical, Biomedical, etc.)
• Masters or advanced degree preferred.
• 7 -10 years experience in Pharmaceuticals, Medical Devices, Biotechnology or other related industries.
• Program management of Device projects
• Experience with usability testing / user studies / human factors
• Demonstrated leadership skills especially the management of high-visibility project teams
• Demonstrated knowledge of parenteral delivery devices (syringes, self/ or auto-injectors), etc.
• In-depth understanding of device verification including functional testing, process validation/verification, quality assurance, and regulatory requirements as they pertain to and devices.
• Ability to work strategically and independently with internal and external groups on multiple projects.
• Excellent written and verbal communication skills with demonstrated ability to establish and maintain effective communications internally and with external manufacturing partners.
• Competency in use of business and project management computer software (such as MSProject and MSOffice).
• Capable of transporting self to various work locations. If using own motor vehicle, must have current, valid US driver's license and proof of insurance coverage that at least meets current minimum requirements of the licensing state.

At Otsuka, we defy limitation, so that others can too.

We have an unwavering belief in doing more. In transcending expectations. In going above and beyondunder any circumstancesfor patients, families, providers, and for each other. Its this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.
We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology.

Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho the achievement, completion, and discovery of truth; and Sozosei pursuing that which only Otsuka is capable of delivering. We approach our business and overcome challenges through perseverance, unconventional thinking and humility.
Learn more about Otsuka Pharmaceutical Company on its global website at http://www.otsuka.co.jp/en . Learn more about Otsuka in the U.S. at www.otsuka-us.com .