Senior Engineer Biotech Combination Products JP11782C
Senior Engineer Biotech Combination Products JP11782C
Posted on :
05-04-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Job Title: Senior Engineer Biotech Combination Products (JP11782C)
Location: Cambridge MA. OR Thousand Oaks CA.
Business Unit: Prefilled 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.
Job Description:
Ideal candidate: Minimum of 1 YOE project managing experience. 510 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 crossfunctionally 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 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
510 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 36 team members.
Series of 1:1 interviews
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our websitewww.3keyconsulting/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
Location: Cambridge MA. OR Thousand Oaks CA.
Business Unit: Prefilled 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.
Job Description:
Ideal candidate: Minimum of 1 YOE project managing experience. 510 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 crossfunctionally 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 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
510 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 36 team members.
Series of 1:1 interviews
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our websitewww.3keyconsulting/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
Regards
3KC Talent Acquisition Team
Required Experience:
Senior IC
Employment Type
Hourly
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
