Simply Biotech · 1 day ago
Manufacturing Engineer - 21861
Oceanside, CA
Full-time
Onsite
Mid Level
$48/hr - $57.70/hr
3+ years expSimply Biotech is an exciting biotech company seeking a Manufacturing Engineer to support manufacturing engineering activities for medical devices. The role involves process development, troubleshooting, and quality support, while collaborating with cross-functional teams to achieve project milestones.
BiotechnologyHealth CareHealth DiagnosticsMedical DevicePersonal DevelopmentStaffing Agency
Responsibilities
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 suppliers
Work 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
Qualification
Required
Bachelor's degree in an engineering discipline
3-5+ years of medical device experience
Proficiency with SolidWorks
Prior IQ/OQ/PQ validation experience
Experience writing SOPs
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 Office
Ability 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 support
Experience with equipment controls, equipment qualification, and process validation support
Willingness to learn high-pressure polyurethane foam equipment and grow into an in-house subject matter expert over time
Ability to work with automation engineering consultants to help implement new manufacturing equipment
Solid SolidWorks proficiency, including the ability to take legacy PDF or 2D CAD drawings and migrate them into proper SolidWorks models
Comfortable improving or redesigning basic fixtures and tooling to support manufacturing efficiency
Preferred
SolidWorks
Minitab
OrCAD
Failure analysis
Lean Six Sigma
Machining experience
Lab view
Statistics
Technical communications
Project management
Mechatronics engineering
Benefits
401(k)
Health insurance
Company
Simply Biotech
Simply Biotech is a medical-related staffing agency.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Matthew Bowers
COO and General Counsel
Company data provided by crunchbase