What are the responsibilities and job description for the Manufacturing Engineer - 21861 position at Simply Biotech?
Manufacturing Engineer - Simply BiotechOVERVIEWAre you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below. Immediate opening for a Manufacturing Engineer in Oceanside, CA who possesses:Bachelor's degree in an engineering discipline3-5 years of medical device experienceProficiency with SolidWorksPrior IQ/OQ/PQ validation experienceExperience writing SOPs Email resumes to tness@simplybiotech.com and call 858.258.6501. FULL DESCRIPTION: This role is responsible for supporting manufacturing engineering activities for medical devices. Responsibilities will include manufacturing process development and support, process characterization, production troubleshooting, equipment and tooling support, verification and validation activities, risk documentation, specification and work instruction development, and continuous improvement initiatives. This role will also become knowledgeable in the operation and optimization of high-pressure polyurethane foam dispensing and molding equipment. The selected candidate will be responsible for: Product Development: Under direction of more senior staff, design, develop, test and refine cost-effective device prototypes to enable in vitro and in vivo testing. Conduct studies to demonstrate feasibility of a product concept. Develop processes necessary to fabricate devices. Develop and implement test methods for assessing the quality of in-process and finished products. Develop, execute and analyze design verification and validation studies.Project Management/ Participation: Work with other Engineering and cross-functional employees to achieve company and department milestones on time and on budget. Maintain flexibility in a highly dynamic environment working with highly dedicated cross-functional colleagues in a culture focused on continuous improvement. Manufacturing Support: Implement improvements to manufacturing processes and process flow. Develop fixturing or other tools necessary for efficient manufacturing operations. Conduct equipment preventative maintenance or qualification studies as necessary. Conduct preclinical build operations as necessary. Support process validation activities.Quality Support: Write, amend and review SOP's, batch records, raw material specifications, drawings and other documentation as required to support product manufacturing and quality control testing. Support resolution of non-conforming material or corrective actions (CAPAs).Engineering/Scientific Acumen: Generate and present scientific data, including scientific papers and research reports.Documentation: Throughout the course of all job activities, maintain accurate records and documentation as prescribed in the Quality System Regulation (QSR) established by the FDA (21 CFR Part 820).Work closely with Quality to help qualify new components and suppliersWork closely with Maintenance to identify gaps and improve equipment processes Partner with QA on customer-driven projects, including new product introductions, changes, and resolve problems Support and own manufacturing-related CAPA action items Be flexible—someone who can shift between engineering, manufacturing, quality, and customer needs as priorities change The selected candidate will also possess: Bachelor's Degree (BS) in Mechanical Engineering, Electrical Engineering, or other technical degree from four-year college or university, or 4 years of related experience and/or training, or equivalent combination of education and experience.Computer skills required: Microsoft OfficeOther preferred skills: SolidWorks, Minitab, OrCAD, Failure analysis, Lean Six Sigma, Machining experience, Lab view, Statistics, Technical communications, Project management, Mechatronics engineeringAbility to write clear, practical procedures and work instructions for production (this is very important) Strong hands-on manufacturing skills, including troubleshooting, fixture improvement, and equipment supportExperience with equipment controls, equipment qualification, and process validation supportWillingness to learn high-pressure polyurethane foam equipment and grow into an in-house subject matter expert over timeAbility to work with automation engineering consultants to help implement new manufacturing equipmentSolid SolidWorks proficiency, including the ability to take legacy PDF or 2D CAD drawings and migrate them into proper SolidWorks modelsComfortable improving or redesigning basic fixtures and tooling to support manufacturing efficiency Salary Range: $48 – 57.70/hourFor immediate and confidential consideration, please email your resume to tness@simplybiotech.com and call 858.258.6501. More information can be found at www.simplybiotech.comCompany DescriptionSimply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.
Salary : $48 - $58