Engineer, Biopharma Medical Device (JP10473)
About The Position
The Device Engineer will participate in the design development and lifecycle management related design center activities for commercialized drug delivery devices. This includes technical operations support for contract manufacturing, failure investigation, leading and assessing design changes, develop test procedures, scale-up and global launch, supplier development, and continues improvement. Scope includes mechanical delivery devices, such as; Prefilled syringes. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical and electro-mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as developing product enhancements, analytical failure analysis and implementing design solutions, assessment of proposed changes, product launches, and defending inspection and follow through of commitments.
Requirements
- Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments, plans and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devises new approaches to problems encountered.
- At a minimum familiar with the following standards and regulation: Quality System Regulation – 21CFR820, Risk Management – ISO 14971, EU Medical Device requirements – Council Directive 93/42/EEC
- BS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology with 3+ years of experience within the pharmaceutical/biotechnology industry.
- Must have hands on Laboratory experience in a GLP Setting (Science or Engineering Lab)
- BS Degree in the field of Mechanical, Chemistry, Biomedical, Engineering, or any science degree
- Seeking a candidate with regulated work environment experience
Nice To Haves
- Degree in the field of Mechanical or Biomedical
- Medical device industry experience and regulated work environment experience
- Background in developing and commercialization of medical devices and knowledge of manufacturing processes
- Strong understanding and experience in design controls, failure investigation, initiating and bringing complex projects to conclusion and the ability to work independently and dynamic cross functional teams
- Fill-Finish experience is a bonus but not mandatory.
Responsibilities
- Accountability of maintaining technical records within design history file associated with assigned products
- Develop Test Method, generate and maintain design specification, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, etc.
- Lead system level root cause investigation, coordinate design improvements with development partners, strategic planning and execution of design changes and improvements.
- Works with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications
- Individual contributor with Leadership attributes to effectively represent device engineer within a large network/matrix organization
- Support a senior engineer on a variety of projects related to laboratory testing, life cycle management, and product-based initiatives regarding prefilled syringes in both the commercial and developmental space.
- Author protocols, reports, and further technical documentation while adhering to GMP standards.
- Perform laboratory testing using an Instron force tester and vision systems.
- Complete a wide variety of supporting tasks for projects in a timely manner while maintaining a high standard of quality.
Benefits
- Supplement additional workload on team.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
