Principal Engineer - Biotech F&E (JP4507

Location: Woburn, MA
Date Posted: 07-23-2018
Job Title: Principal Engineer - Biotech F&E (JP4507)
Location: Woburn, Massachusetts 01801
Employment Type: Contract
Duration: 12 months with likely extensions
Business Unit: F&E
‚Äč3Key Consulting is looking for a Principal Engineer for a leading, international pharmaceutical company headquartered in Thousand Oaks, CA
Job Summary:
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 Principle Engineer 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.
- 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.
- 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
 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.
Important Note: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need only to apply and will be considered!!!
Top Must have Skill Sets:
1. Must have experience in engineering Facilities and utilities (Water system, HVAC, steam, etc..)
2. Must have experience handling an auditor and understanding the GMP procedures and policies.
3. Must have the technical skills to assist the technicians at the site.
4. Project management experience would be a preferred skill set.
The Principal Engineer is responsible for managing the maintenance and execute projects related to the Utilities at the Woburn, MA biotech manufacturing site.
The Principal Engineer will ensure execution of a safe, compliant, effective, efficient, and cost appropriate operations & maintenance programs.
Day-To-Day Responsibilities:
• Provide leadership for 24/7 field support to troubleshoot, identify, and resolve utilities issues.
• Own the equipment’s and/or systems related to the utilities.
• With minimal direction, provide coaching and technical expertise to the technicians to support the manufacturing operations.
• Identify and implement opportunities to improve equipment & process reliability and minimize impact of maintenance activities to ongoing operations.
• Provide leadership to continuously improve execution strategies throughout the site and across all shifts.
• Effectively collaborate with key customers and support groups regarding operations & maintenance activities and strategies.
• Collaborate effectively with Facilities & Engineering peers within the Amgen manufacturing network.
• Ensure activities are accomplished in a safe manner.
• Ensure activities are accomplished in accordance with cGMP requirements and expectations.
Employee Value Proposition: Provide opportunity to manage entire portfolio, maybe in another company you will be an expert in just water systems but here you will manage all aspects of the site. They will be able to see all steps in manufacturing the product at the site.
Red Flags: Lack of engineering background.
Interview Process: Phone and in-person.
We invite qualified candidates to send your resume to If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website You are welcome to also share this posting with anyone you think might be interested in applying for this role.**No Third-party Vendors Please**
3KC Talent Acquisition Team
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