Sr/Principal Mechanical Engineer

Location
Gaithersburg, MD, US
Posted
Jun 13, 2021
Ref
732855300
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

This position could be remote
The Principal Mechanical Engineer will be responsible for technical leadership in the design, development, and testing of drug delivery devices including auto-injectors and nasal spray devices.

They will be responsible for successful execution of engineering activities involved in conceptualization, feasibility, design, development, transfer to manufacturing and launch of new products for the Device Business Unit.

They will lead medical device engineering activities and serve as device technical lead on one or more projects. They will design and develop medical devices and oversee the engineering work of multiple contractors including design firms, laboratories, and manufacturing organizations.

II: Responsibilites
TECHNICAL:

• Lead design of drug-delivery devices
• Analyze, design, and develop solutions to engineering challenges associated with complex mechanical and fluidic assemblies
• Create & review 3D models, engineering drawings, specifications, tolerance analyses, DFM/DFA, and other design collateral
• Develop and execute test plans for development, verification, and validation of designs
• In collaboration with manufacturing teammates, develops fabrication and assembly processes for new products and ensures Design for Manufacturability.
• Collaborate with Manufacturing Engineering on the design and selection of tooling and production equipment for successful transfer of new products to manufacturing.
• Develop intellectual property through invention disclosures and patent writing
• Analyze standards (ISO, ASTM, USP, etc.) and guidance documents (FDA, ICH, etc.)
• Perform risk analyses for drug-delivery devices, in accordance with ISO 14971.
• Document results in reports such as dFMEA, pFMEA, FTA, Risk Management Report
• Assist and lend expertise in engineering problem solving activities related to existing products for the Device Business Unit.
• Maintain Design History File
• Oversee evaluation of changes (component, product, process) pre-design transfer.

LEADERSHIP:

• Deliver and ensure execution to plans and schedules that fully describe the engineering tasks and resources required to design, transfer and launch new products.
• Take ownership for guiding new products through the medical device Design Control process, with a thorough working knowledge of the requirements of 21CFR820.30 and ISO 13485
• Collaborate with colleagues on an integrated team to provide medical device subject matter expertise to create and advance products from concept to commercialization
• Develop and document cross-functional plans and strategies
• Prepare risk mitigation plans and cost-effective strategies to ensure delivery of new products within time, cost and quality constraints.
• Lead & mentor other engineers and technical staff
• Oversee device design firms & manufacturers in the development of delivery devices
• Oversee contract research laboratories for device performance testing
• Drive and lead engineering Design Reviews & Technical Reviews

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
• A minimum of a Bachelor's or advanced degree in Mechanical Engineering (or a related engineering discipline). Master's degree preferred.
• 10+ years experience in medical device design and development. Multiple successful product launches preferred.
• Experience with combination product/drug delivery devices including auto-injectors, injection pens, reconstitution and dissolution devices, patch/pumps, pre-filled syringes, nasal spray devices, inhalers or other novel delivery technologies is highly preferred
• Knowledge of FDA 21 CFR part 820, ISO 13485 Design Control and ISO 14971 Risk Management for Medical Devices is essential.
• Proficiency with 3D computer-aided design (SolidWorks preferred)
• Experience with part and assembly design utilizing injection molding and associated tooling, materials and machinery
• Experience with Geometric Dimensioning and Tolerancing (GD&T) and tolerance stack-up analyses
• Experience with Design of Experiments (DOE) and statistical analysis
• Experience with modeling tools such as MATLAB and Finite Element Analysis
• Demonstrated ability to manage requirements. Experience with tools such as JAMA, JIRA, or Helix preferred.
• Track record of successfully managing third-party engineering design sub-contractors is essential
• Excellent written communication skills and the ability to rapidly and robustly document DHF deliverables.
• Strong communication skills and ability to drive cross-functional decision making
• Thorough knowledge of industry standards, FDA guidance, quality systems, verification, validation, design transfer, and quality engineering principles for medical devices and combination products
• Demonstrated ability to create and execute to technical plans and timelines (MS Project preferred)
• Experience mentoring other engineers and technical staff is preferred.

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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