Engineer Senior Combination Medical Devices JP11927
Engineer Senior Combination Medical Devices JP11927
Posted on :
05-04-2025
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Job Description
Job Title: Engineer Senior Combination Medical Devices (JP11927
Location: Louisville KY. 40201
Business Unit: Logistics and Transportation
Employment Type: Contract
Duration: 1 years (with possible extensions)
Rate: $44 $46/hour W2
Posting Date: 10/26/2023
Notes: VERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering Mechanical Engineering OR Systems/Software Engineering background need apply and will be considered!!! Onsite preferred. (Hybrid in the office monthly to bimonthly). Remote MUST adhere to Eastern time zone. *** Please provide sample writing if available
3 Key Consulting is recruiting an Engineer Senior Combination Medical Devices for a consulting engagement with our direct client a leading global biotechnology company.
Job Description:
The Ideal Candidate:
Summary of Role:
Top Must Have Skill Sets:
Day to Day Responsibilities:
Basic Qualifications:
Why is the Position Open
Supplement additional workload on team.
Red Flags:
Interview Process:
1:1 Phone then 1:2 Webex interview. Available to begin interviews 10/27/23
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: Louisville KY. 40201
Business Unit: Logistics and Transportation
Employment Type: Contract
Duration: 1 years (with possible extensions)
Rate: $44 $46/hour W2
Posting Date: 10/26/2023
Notes: VERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering Mechanical Engineering OR Systems/Software Engineering background need apply and will be considered!!! Onsite preferred. (Hybrid in the office monthly to bimonthly). Remote MUST adhere to Eastern time zone. *** Please provide sample writing if available
3 Key Consulting is recruiting an Engineer Senior Combination Medical Devices for a consulting engagement with our direct client a leading global biotechnology company.
Job Description:
The Ideal Candidate:
- Individual must have background with data analysis.
- Ability to receive validate and manipulate those reports.
- Excellent technical writing skills.
- Prefers a Masters in Engineering and 3 YOE.
- Must have experience in a GMP environment.
- Needs to have Biotech/Pharma/ Med Device exp.
Summary of Role:
- 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 microinfuser delivery pump systems.
- The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electromechanical medical devices.
- The Senior 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 Senior Engineer is to work within a crossfunctional organization to utilize technologies and methodologies that support shortcycle robust device development.
Top Must Have Skill Sets:
- Technical writing skillsexperience in writing on owning GMP documents and records.
- Oversight and management of multiple projects and tasks for 3rd party suppliers.
- Data analysis to develop insights and strategies.
Day to Day Responsibilities:
- Management of 3rd party supplier ensuring Quality Agreement is adhered to Quality record ownership.
- Tracking of key metrics and performance indicators.
- 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.
- Create and execute 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:
- Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR
- Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience.
- 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 electromechanical 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 21CFR820
- 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.
Why is the Position Open
Supplement additional workload on team.
Red Flags:
- Extensive job history within short period of time
- No experience in GMP working environment
Interview Process:
1:1 Phone then 1:2 Webex interview. Available to begin interviews 10/27/23
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
Employment Type
Hourly
Key Skills
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