3 Key Consulting, Inc.

Senior Engineer, Biotech Combination Products (JP11782C)

3 Key Consulting, Inc.  •  $45 - $51/hr  •  Cambridge, GB (Onsite)  •  18 days ago
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Job Description

Job Title:  Senior Engineer, Biotech Combination Products (JP11782C)
Location: Cambridge, MA.  OR Thousand Oaks, CA.
Business Unit: Pre-filled Syringes and Lyo Kit Platforms
Employment Type:  Contract
Duration: 18+ months (with possible extensions)
Rate $45 - $51/hour W2
Posting Date: 09/13/2023
Notes: Only qualified candidates need apply.  Onsite, with some WFH flexibility.

3 Key Consulting is recruiting an Senior Engineer, Combination Devices for a consulting engagement with our direct client, a leading global biotechnology company.


Ideal candidate: Minimum of 1 YOE project managing experience. 5-10 YOE in Engineering with background in med device, biotech, (Aero and Auto would also be considered). Bachelors or Masters Preferred. Preferred systems experience: Solid works, CAD, Smartsheet'

Lead and support the Prefilled syringe combination product platform team in both development and commercial lifecycle of prefilled syringe (PFS) configurations. Experience leading and managing project timelines and initiatives while reporting out to management. Scope includes a the full range of PFS devices and variants, such as; needle protection systems and different delivery volumes. The qualified candidate will lead technical teams to ensure successful device development of these mechanical devices. The Senior Engineer will work closely with team members acting as a project manager to develop detailed timelines for ensuring engineering specifications, device design & development, verification, validation, and regulatory submissions of these devices are completed on time.

Top Must Have Skill Sets:
Project Management
Technical understanding of design controls
Device Engineering experience

Day to Day Responsibilities:
Supporting platform and product development teams by acting as a project manager to ensure timelines and delivery dates are met. Providing technical support and insights to team members and leading platform initiative projects.

- Create and execute to project plans and schedules; responsible for ensuring team meets project timelines
- 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.
- Support development, execution, and review of 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
- 5-10 years current experience with engineering processes and procedures.
-Project Management experience
- Strong background in engineering and commercialization of 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
- Experience in drug/device combination product design and development
- Strong problem solving, risk assessment, and risk management skills
- Must be capable of working on multiple projects in a deadline driven environment.

Preferred Qualifications:

Why is the Position Open?
Supplement additional workload on team

Red Flags:
No Job hopping

Interview Process:
Initial Phone screenings and then Webex interviews with a panel of 3-6 team members.
Series of 1:1 interviews

We invite qualified candidates to send your resume to  resumes@3keyconsulting.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.
3 Key Consulting, Inc.

About 3 Key Consulting, Inc.

3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries. With 12 years of experience, 3Key has established a vast network of industry professionals and forged strong partnerships/alliances with key academic institutions across the country to continually develop our business professional and niche skill pipeline.

3KC offers a full suite of staffing solutions including PEO and compliance services. 3KC has several technology and industry domain practices including competencies in business intelligence, healthcare and life sciences.

People, process, and technology are 3 key areas of focus that we carefully examine individually and jointly, in order to deliver on our client's 3 key areas of focus - better, faster and cost effective BI and staffing solutions.

MISSION:

To create a better work experience for our customers, partners and employees through exceptional dedication and performance.

• We make hiring easier

• We build strong teams

• We bring about positive outcomes

VISION:

3 Key Consulting’s responsibility is to continually improve the manner and efficiency in which human resources and businesses are brought together to create value. Our vision is to put programs into action that improve market efficiencies while helping businesses and people be more productive.

Industry
Unknown
Company Size
1-10 employees
Headquarters
Simi Valley, CA
Year Founded
2009
Website
3keyconsulting.com
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