1+ months

Director Devices

Gaithersburg, MD 20877


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 Sr Manager/Director will be the technical lead for projects, overseeing engineering and development of medical devices and combination products.
-The Sr Manager/Director will investigate/evaluate existing off the shelf technologies and advise R&D, Quality, Regulatory Affairs, and Tech Ops to ensure appropriate device development under ISO and FDA standards.
-They will also develop new devices from initial proof of concept to market release.
-Focus will be placed on characterizing and optimizing a variety of delivery devices for multiple products.
-An expert in ISO13485, the Sr Manager/Director will ensure all projects maintain detailed and traceable documentation throughout all phases of R&D and will coordinates activities with internal and external resources to ensure the delivery of supplies/services needed to meet timelines.

II: Responsibilities
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Lead a team of device engineers on project teams through all phases of the product development process.
Develop new device designs and optimize existing designs.
Direct work utilizing internal resources or external sub-contract laboratories and manufacturing organizations.
Work closely with and direct device developers and manufacturers to obtain an in-depth understanding of the components and performance of the delivery devices.
Provide direction on design; design experiments, oversee execution, analyze and interpret data to understand drug delivery device reliability and performance.
Plan and execute projects from concept through initial production ramp-up, working hand in hand with all parties to ensure a commercially stable device.
Post launch provide input/guidance on the impact of changes to device performance.
Work with manufacturing and suppliers to produce prototypes and lead activities to optimize designs (including trainers) for manufacturability.
Work closely with internal and external teams to develop products with a focus on transferring the design to ensure reliability, manufacturability, and commercial longevity.
Coordinate and execute device design verification activities per the necessary standards.
Provide pre-clinical device development and support
Significantly contribute to aspects of project management including scope definition, scheduling, budgeting, and contingency planning.
Develop in-house device delivery testing capability.
Work closely with Regulatory to support regulatory filings.
Analyze and present data to project teams and management
Regularly interacts with functional senior management.
Write study protocols, SOP, and technical reports.
Lead a team of employees hiring & training of employees, planning assigning & directing work, appraising performances, rewarding and disciplining employees, addressing grievances and resolving problems, developing sound technical and decision making skills, and empower team members through delegation and collaboration.
Develop, set and communicate sustainable targets and goals for direct reports/teams.
Create a supportive work climate that enable staff members to develop professionally, values diversity and open communication, promotes teamwork and collaboration, and stresses quality, safety, customer satisfaction and profitability/cost effectiveness.
Conduct all work in compliance with Emergents Standard Operating Procedures and regulatory requirements.
Other duties as assigned.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects managements assignment of essential functions.

III: Minimum Education, Experience & Skills
Bachelor Degree (BS) in Mechanical or Biomedical Engineering or related field required; advanced degree preferred
10 years+ related work experience required, with a minimum of 4 years of people leadership
Must have led at least one injection device development program from concept evaluation, through all development stages, to successful launch
Experience with Design for Six Sigma or similar methodologies preferred.
Proven history of statistics application in product development required
Expert knowledge of ISO13485, Design Controls, ISO11608 series, and various risk management methodologies, ISO14971.
Expertise in the development and optimization of injection molded components and machined metal components.
Knowledge of material properties (including sterilization compatibility), component manufacturing and high-volume assembly processes.
Knowledge of device and combination product regulations, regulatory pathways and filings.
Skilled at leading and accomplishing work through others (e.g., suppliers, partners, colleagues)
Proficiency with 3D computer-aided design (SolidWorks) is beneficial
Knowledge of Microsoft Office Products and other design computer applications (i.e.: Word, Excel, PowerPoint & Project, Windows, Visio, and Statistical Software)
Ability to exercise independent judgment consistent with department/Company guidelines
Excellent organizational ability and working well in a fast-paced, team-oriented, collaborative way is required.
Excellent communication skills and strong interpersonal skills.
Highly organized, with exceptional time management and prioritization
Critical thinking evaluation of process problems
Strong work ethic
Flexibility to travel on company business when required.

Ability to maintain up-to-date knowledge of procedures, guidances, products and activities of assigned area

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.

Categories

Industry

  • Biotechnology
Posted: 2022-03-30 Expires: 2022-05-29

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Director Devices

Emergent BioSolutions Inc.
Gaithersburg, MD 20877

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