Engineer Principal, Medical Device Development & Packaging C&Q - (JP14217)
- New Albany, OH
- $51.00-56.00 per hour
- Contract
- Full-time
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: Site Process development
Duration: 1+ years (with possible extension)
Posting Date: 07/07/25
Pay Rate: $51 - $56/hour W2
Notes: Only qualified candidates need apply. Onsite AOH - Monday - Friday - Standard 8-5. Very occasional need to have candidates work later into the day due to occasional set up that may be needed. Approximately 1-2x per month.3 Key Consulting is hiring an Engineer Principal, Medical Device Development & Packaging C&Q for a consulting engagement with our direct client, a leading global biopharmaceutical company.Job Description:
Our ideal candidate will have 10 years of experience. (See below for details). This position will be onsite in New Albany, OH., Monday - Friday - Standard 8-5. Very occasional need to have candidates work later into the day due to occasional set up that may be needed. Approximately 1-2x per month.
- The qualified candidate will lead teams in the development of drug delivery devices. Scope includes a wide range of devices, such as: needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems.
- The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices.
- The candidate will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices.
- The role of the Principle Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.
Planned ProjectTop Must Have Skills:
- Material & test specs generation, protocol & report writing.
- Process & test development, prototyping, design verification.
- DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
- Nice to have: packaging process experience
Position involves support of Senior Staff on initiation, design, and delivery of projects, particularly for Packaging Equipment C&Q, Characterization and Validation. Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms. Responsibilities include:
- Work cross-functionally with individuals and project teams in Marketing, Operations, and Development.
- Create and assess product requirements to determine technical coverage and proper integration different subsystems.
- Create and execute to project plans and schedules
- Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
- Provide deep technical assistance for junior engineers.
Doctorate degree and 3 years of experience OR Masters degree and 5 years of experience OR Bachelors degree and 7 years of experience OR Associates degree and 12 years of experience OR High school diploma / GED and 14 years of experience.
- BS in Engineering and previous experience in a medical device industry
- 10 years current experience with engineering processes and procedures.
- Led projects from development through the 510k and PMA approval process.
- Strong background in engineering and commercialization of electro-mechanical medical devices.
- Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
- Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
- Experience in drug/device combination product design and development
- Familiar with the following standards:
- Quality System Regulation 21CFR820
- Risk Management ISO 14971
- EU Medical Device requirements Council Directive 93/42/EEC
- Medical Electrical Equipment EN 60601
- Small scale device assembly experience.
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Strong problem solving, risk assessment, and risk management skills.
- Must be capable of working on multiple projects in a deadline driven environment.
- VERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered!!!
Not flexible for the working shift/hours required. Approximately 1-2x per monthInterview process:
One round panel interviewWe invite qualified candidates to send your resume to . If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.