Engineer, Biopharma Medical Device (JP10473)

Job Description: 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.

Essential Skills and Responsibilities: 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. 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. 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/EECBasic QualificationsBS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology with 3+ years of experience within the pharmaceutical/biotechnology industry.

Preferred Qualifications: 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 Excellent written and verbal communication skill Why is the Position Open? Supplement additional workload on team. Top Must-Have Skill SetsMust 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 Day to Day Responsibilities The device engineer will 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. The engineer will be expected to author protocols, reports, and further technical documentation while adhering to GMP standards. Laboratory testing will primarily include the use of an Instron force tester and vision systems. The identified candidate must be able to lift up to 50 lbs for receipt and transferring of material. Fill-Finish experience is a bonus but not mandatory. Engineer will be evaluated on ability to complete a wide variety of supporting tasks for projects in a timely manner while maintaining a high standard of quality. Red FlagsNo laboratory experience or desire to work in a lab environment 3. No desire to work in cross-functional team environment 4. No technical writing skills 5. No BS degree Employee Value Proposition To work for a dynamic team

Interview Process: Webex with HM Panel interview We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you're not interested in pursuing this position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.