Planet Pharma
Base pay range
$46.00/hr - $53.00/hr 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. About the Role
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. Responsibilities
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 Qualifications
BS in Engineering (Mechanical or Electrical) and previous experience in a medical device industry PHD+ 3yrs experience OR Master's degree + 5yrs of experience OR BA/BS + 7yrs of experience OR Associate's degree + 12 years of experience 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 Required Skills
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 Preferred Skills
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 Seniority level
Mid-Senior level Employment type
Full-time Job function
Biotechnology Research and Medical Equipment Manufacturing Referrals increase your chances of interviewing at Planet Pharma by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Sign in to set job alerts for “Mechanical Engineer” roles.
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$46.00/hr - $53.00/hr 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. About the Role
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. Responsibilities
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 Qualifications
BS in Engineering (Mechanical or Electrical) and previous experience in a medical device industry PHD+ 3yrs experience OR Master's degree + 5yrs of experience OR BA/BS + 7yrs of experience OR Associate's degree + 12 years of experience 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 Required Skills
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 Preferred Skills
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 Seniority level
Mid-Senior level Employment type
Full-time Job function
Biotechnology Research and Medical Equipment Manufacturing Referrals increase your chances of interviewing at Planet Pharma by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Sign in to set job alerts for “Mechanical Engineer” roles.
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr