About this role
AbbVie is hiring a Scientist I Medical Device Mechanical Engineer to support development and industrialization of injection devices used to deliver AbbVie medicines. The role spans lab studies, CAD development, documentation, statistical analysis, and design control activities for regulated medical device systems.
Key Responsibilities
- Design and execute laboratory studies supporting product development and on-market investigations
- Support design transfer and industrialization activities
- Support manufacturing process development activities
- Maintain product design documentation
- Perform statistical data analysis and develop protocols with documented test results
Technical Overview
This position focuses on medical device mechanical engineering for injection systems, including laboratory testing, statistical data analysis, and producing 3D/2D CAD models in a PDM environment with GD&T and engineering drawings. Work includes design transfer, manufacturing process development support, and design controls compliant with ISO 13485 and CFR 820.30.
Ideal Candidate
The ideal candidate is an entry-level mechanical or biomedical engineering professional with 3-5 years of experience (or an MS with up to 2 years) supporting medical device development in a regulated environment. They can execute laboratory studies, perform statistical data analysis, and develop 3D/2D CAD in a PDM environment with strong documentation and design control knowledge (ISO 13485 / CFR 820.30).
Must-Have Skills
laboratory studiesdesign and execute laboratory studies supporting product development and on-market investigations3D and 2D CAD development in PDM environmentperform statistical data analysisdevelop protocolsand document test results3D CAD modelingdetailed engineering drawingsproduct database management environment and GD&Tdesign controls (in accordance with ISO 13485 / CFR 820.30)
Nice-to-Have Skills
Physical prototyping (including 3D printingmanual machiningetc.) and reverse engineeringreverse engineeringKnowledge of material propertiesmaterial selection and testing methodologiesexperience with toolroom environmentmanufacturing process development
Tools & Platforms
3D and 2D CADPDM environment
Required Skills
laboratory studiesproduct developmenton-market investigationsdesign transferindustrializationmanufacturing process developmentproduct design documentationproduct design changescontinuous improvementstatistical data analysis3D and 2D CAD developmentPDM environmentdevelop protocolsdocument test results3D CAD modelingdetailed engineering drawingsproduct database management environmentGD&Tstatistical analysis toolsmanufacturing processesdesign controlsISO 13485CFR 820.30toolroom environmentmaterial propertiesmaterial selectionmaterial testing methodologiesexperiment planningmaterial controlrecordkeeping
Hard Skills
laboratory studiesproduct developmenton-market investigationsdesign transferindustrializationmanufacturing process developmentproduct design documentationproduct design changescontinuous improvementstatistical data analysis3D and 2D CAD developmentPDM environmentdevelop protocolsdocument test results3D printingmanual machiningreverse engineering3D CAD modelingdetailed engineering drawingsproduct database management environmentGD&Tstatistical analysis toolsmanufacturing processesdesign controlsISO 13485CFR 820.30toolroom environmentmaterial propertiesmaterial selectionmaterial testing methodologiesexperiment planningmaterial controlrecordkeeping
Soft Skills
Strong communication skills (both written and verbal)self-motivatedteam environmentability to follow assigned schedulesStrong design and analytical skillscross-functional collaboration
Keywords for Your Resume
Scientist I Medical Device Mechanical EngineerMedical Device Mechanical EngineerMechanical EngineeringBiomedical Engineeringlaboratory studieson-market investigationsdesign transferindustrializationmanufacturing process developmentproduct design documentationcontinuous improvementstatistical data analysis3D and 2D CAD developmentPDM environmentdevelop protocolsdocument test results3D CAD modelingdetailed engineering drawingsGD&TISO 13485CFR 820.303D printingmanual machiningreverse engineeringtoolroom environmentdesign controlsmaterial propertiesmaterial selection
Deal Breakers
Must have experience executing laboratory studies supporting product development and on-market investigations, Must have 3D and 2D CAD development experience in a PDM environment, Must demonstrate knowledge of design controls in accordance with ISO 13485 and CFR 820.30
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