This is an Individual Contributer position, reporting to the Director/Associate Director of Device Development and Technology. This individual will be responsible for Program management of Device development. They will also 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
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.
Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: Otsuka-people creating new products for better health worldwide. Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a big venture company at heart, applying creativity in everything it does.
Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 50,000 people worldwide and had consolidated sales of approximately USD 11 billion ( 9.9 billion) in 2016.
All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en . Learn more about Otsuka in the U.S. at www.otsuka-us.com .
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
At Otsuka, our people are passionate about developing and delivering original products as part of a global holistic commitment to better health and well-being. We have two core businesses dedicated to achieving our goals: a pharmaceutical business and a nutraceutical business. The pharmaceutical business develops and markets products for the diagnosis and treatment of disease in the following areas: central nervous system, oncology, gastroenterology, ophthalmology and cardiovascular. The nutraceutical business is dedicated to maintaining and improving health through the use of foods and beverages that provide extra health benefits in addition to their basic nutritional value. Since the beginning, nearly 100 years ago, the Otsuka family sought to develop products that stood out from the crowd, by traveling down the paths of discovery where others were less likely to tread.
We believe our culture and our people are the differentiators that empower us to produce breakthrough results. This is what makes us a big venture company that takes risks and focuses on unmet medical needs in order to develop new and better therapeutic compounds. We harness the extraordinary cr...eative and innovative abilities of our people to solve problems differently, and to persevere until they find answers. We are in this for the long-haul. Otsuka is a highly ethical company. We adhere to the highest standards in how we develop and deliver our products, and in how we treat our most valuable assets: Otsuka-people. We encourage them to follow their dreams, as turning dreams into reality is at the core of everything we do. It paves the way ahead to achieve our shared purpose: impacting on human health to help people live better lives.