ACL Digital
Senior Executive – US TAG at ACL (Pharmaceuticals, Life Sciences and Medical Devices)
Job Title: Principal Medical Device Engineer
Location: New Albany, OH
Duration: 12 Months
Onsite AOH – Monday to Friday, Standard 8‑5. Occasional need to work later into the day; approximately 1‑2 times per month. Planned travel abroad. CANDIDATES MUST BE ABLE TO TRAVEL INTERNATIONALLY.
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. The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro‑mechanical medical devices. The Principal 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 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 of 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
Skills and Qualifications
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 510(k) 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
Familiar with the following standards: Quality System Regulation 21 CFR 820, 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
Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, or Engineering background need to apply and will be considered
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Location: New Albany, OH
Duration: 12 Months
Onsite AOH – Monday to Friday, Standard 8‑5. Occasional need to work later into the day; approximately 1‑2 times per month. Planned travel abroad. CANDIDATES MUST BE ABLE TO TRAVEL INTERNATIONALLY.
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. The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro‑mechanical medical devices. The Principal 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 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 of 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
Skills and Qualifications
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 510(k) 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
Familiar with the following standards: Quality System Regulation 21 CFR 820, 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
Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, or Engineering background need to apply and will be considered
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