Principal Engineer – Drug Delivery Device Development; Electro-Mechanical Combination Products JP

Principal Engineer – Drug Delivery Device Development (Electro-Mechanical Combination Products)

3 Key Consulting is hiring a Principal Engineer – Drug Delivery Device Development (Electro-Mechanical Combination Products) for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:

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. International travel may be required for this position.

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
• 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. They 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.

Why is the Position Open?

Planned Project

Top 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

Day to Day Responsibilities:

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.

• 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.

Basic Qualifications:

• BS in Engineering and previous experience in a medical device industry.
• 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
• 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 21
  
  CFR
  820
• 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!!!

Red Flags:

Not flexible for the working shift/hours required and limitation to travel. Approximately 1-2x per month

Unable to travel internationally

Interview process:

One round panel interview

We 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  You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.