Sr. Director, Device Engineering

Location
Gaithersburg, MD, US
Posted
Oct 28, 2020
Ref
686941400
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

I: Job Summary

The Senior Director will lead device engineering for the Device Business Unit . The future portfolio could include a broad array of devices including drug delivery devices for sterile injection, inhalation, and nasal spray products as well as diagnostic devices for detecting public health threats. They will be required to be proficient in all aspects relating to design, development and manufacture of pre-filled syringes, pen injectors, autoinjector and spray devices. They manage the work of internal engineering staff in addition to building and managing our network of external collaborators. They will have strong leadership skills and a track record of product development that they can use to develop and mentor the internal engineering staff. They will be a key member of the R&D leadership team.

II: Responsibilities

The candidate is expected to perform the following:
  • Build & lead a highly effective internal engineering team through talent acquisition and mentoring.
  • Initiate development programs and be the lead on specific projects.
  • Specify the technical requirements for the development program, including performance criteria, materials, analytical methods, test protocols, packages (clinical and commercial) and manufacturing methods.
  • Take ownership for guiding new products through the medical device Design Control process, with a thorough working knowledge of the requirements of 21 CFR 820.30 and ISO 13485
  • Manage ongoing technical programs including developing detailed technical work plans; selecting suitable service for the various activities; managing the performance of the vendors and preparing periodic updates for Sr. Mgmt.
  • Prepare, in conjunction with Regulatory Affairs, the appropriate sections of regulatory filings for the products that they manage.
  • Support Technical Operations to ensure a smooth transfer of technologies and products to commercial manufacturing sites.
  • Enhance internal processes and develop innovations for continuous improvement
  • Create intellectual property covering pharmaceuticals products.
  • Work closely with business development to identify market opportunities for the device platform technologies
  • Work closely with the Grants & Contracts team to respond to RFPs and win external funding


The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

III: Education, Experience & Skills
  • PhD or MS in Biomedical, Mechanical, Chemical or Materials Engineering (or a related engineering discipline) with a minimum of 10 years+ experience in medical device development
  • Direct experience of device development along with drug product device combinations technologies.
  • Direct experience with generating documentation for regulatory filings for drug product device combinations technologies.
  • Broad exposure to drug delivery technologies is preferred
  • Proven project management skills for technical programs.
  • Excellent communication skills and strong interpersonal skills.
  • Flexibility to travel on company business when required
  • Experience in a number of the following is desired: device design, concept development, feasibility testing, requirements management, human factors, process development, risk management, design characterization, V&V, manufacturing, and design transfer, 21 CFR 820.30 and ISO 13485, ISO 14971, IEC 62366, ISO & Military test methods for needle-based injection systems (such as ISO 11608 & Mil-Std-810)
  • A true self starter, who works effectively on their own initiative, and is used to working in demanding environments where there is continuous change and ambiguity
  • Experience working with contract manufacturing
  • Highly organised, with exceptional time management and prioritisation
  • Critical thinking/ evaluation of process problems
  • Strong work ethic


There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

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