Engineer Senior (JP7553)
Thousand Oaks, CA. (MUST BE LOCAL - Onsite Essential – pending lifting of COVID restrictions)
Final Product Technologies Quality
1+ year (with likely extensions)
3 Key Consulting is hiring an Engineer Senior
for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Provide quality oversight with regards to the development of combination products and fulfillment of regulatory commitments. Potential scope of products 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 both lead and/or support technical teams to ensure successful device development and/or fulfillment of regulatory commitments. The role of the Senior Engineer is to provide quality oversight to one or more cross-functional teams to utilize technologies and methodologies that support short-cycle robust device development or accelerated compliance efforts. Responsibilities include:
Why is the Position Open?
- Work cross-functionally with individuals and project teams in Marketing, Operations, and Development.
- Ensure compliance to design controls and fulfillment of user needs during combination product development or design changes, including proper and compliant integration of different subsystems as required.
- Provide quality oversight and guidance regarding the development of process control plans and implementation of process improvements/changes.
- Work with cross-functional teams to develop, qualify, and transfer physical test or inspection methods.
- Provide comprehensive quality guidance and advice to counterparts and stakeholders.
Top Must-Have Skill Sets:
Day to Day Responsibilities:
- Hands on test method qualification and validation experience. (3-5 years of experience).
- Experience working in a cGMP environment for Combination Products or Medical Devices (3-5 years of experience).
- Attention to detail, and ability to communicate to all levels of an organization.(3-5 years of experience).
- Hands on test method qualification and validation experience.
- Experience working in a cGMP environment for Combination Products or Medical Devices.
- Attention to detail, and ability to communicate to all levels of an organization.
Employee Value Proposition:
- BS or BE in Engineering and previous experience in a medical device or pharmaceutical industry.
- 8 years’ current experience with engineering processes/procedures and quality tools.
- 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/validation, DOE/SPC process optimization & validation (IQ, OQ, PQ), P/DFMEA.
- 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.
- Small scale device assembly and/or benchtop testing experience.
- Experience with Automated Test Equipment (ATE).
- Experience with regard to Measurement Systems Analysis/GRR.
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Strong critical thinking, problem solving, risk assessment, and risk management skills.
- Must be capable of working on multiple projects in a deadline driven environment.
- Familiarity with the following standards:
- Quality System Regulation – 21CFR820.
- Risk Management – EN/ISO 14971.
- EU Medical Device requirements – Council Directive 93/42/EEC; Medical Electrical Equipment – EN/ISO 60601
Great way to gain new perspective on combination products. Helping improve the end to end life cycle products.
Lack of practical experience.
Video Skype Panel Interview
We invite qualified candidates to send your resume to email@example.com
. 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.