Manufacturing Engineer

Primary Function of Position
You will be responsible to support and lead various aspects of the dV5 Manufacturing Line, primarily focused on testing processes. This position is highly collaborative, and strong communication/presentation skills are fundamental to successful partnerships with engineering, production and management teams.
Essential Job Duties
Demonstrate ownership of various manufacturing processes, including assembly/test.
Provide real-time (onsite) technical support for issues as they arrive.
Resolve failures of varying complexity, which may be related to process, hardware or software. Identify root cause and implement solutions to improve manufacturability.
Present data and proposals at project team meetings or wider audience forums.
Provide critical DFM (Design For Manufacturability) input to development teams for software processes and electrical-based sub-assemblies.
Develop & utilize understanding of system error codes, P values, UID test functions.
Assist with execution of purges and other major quality control processes for production, when product defects are identified.
Own and execute Production Process Qualifications (PPQ), for the manufacturing line. Assist with major PPQ (full line or factory) validations.
Participate in project teams for CAPAs, MCF (design changes), EDF (field issues), root cause analysis, DPU reduction, process improvements, CAPAs, Cost reduction, etc.
Establish good working relationships with close functions (Production, Quality Eng, Design Eng, Supplier Eng, etc.)
Execute complex DMR/DHR, BOM, and traveler document changes with little oversight.
Translate factory/production data into actions or recommendations for improvements, with understanding of: DPU, yield, CPk, trend charts
Use statistical tools independently to drive data metric reporting and improvements.
Participate in risk analysis project teams whose intentions are to identify compliance gaps that may affect yields and quality metrics. Understands implications of lifecycles, how they are used in product development.
May occasionally informally mentor or supervise colleagues’ work (technicians, documentation specialists, junior engineers, interns)
Performs other duties as required.
Required Education and Training
BS degree in Computer Science/Engineering, Electrical Engineering, Mechanical Engineering, Biomedical Engineering or other similar field.
Required Skills and Experience
3+ years experience in a manufacturing or design-related role
Basic engineering principles and analysis techniques
Solid understanding of computer architecture.
Solid understanding of computer networking and cloud-based computing
Basic experience with software tools/scripting (eg. Matlab, Python, etc.)
Strong communication skills, both written and verbal. Necessary to engage with technicians, production management, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing organizations.
Advanced skills with desktop software applications (Excel, Powerpoint, Word, etc.)
Basic knowledge of process controls, including Six-Sigma, CPk, etc.
High level of personal initiative, including ownership and leadership, to influence product design to improve reliability, robustness and performance.
Troubleshooting ability to systematically and effectively break down a system or process into subparts to identify failures and troubleshoot to component level.
Knowledge and execution of Good Manufacturing Practices (GMP).
Excellent documentation skills and high standards for instructional clarity/accuracy.
High energy and genuine excitement to learn and get to the bottom of problems.
Preferred Skills and Experience
MS degree in an engineering discipline listed above.
Prior experience working in an FDA/ISO regulated environment.
Prior experience with Documentation and production control systems: Agile, SAP, MES
Prior experience in development of: Matlab, Python
Demonstrated ability to effectively design experiments, solve problems and implement them in manufacturing
Expert knowledge (black-belt) of process controls, including Six-Sigma, CPk, etc.
Prior experience evaluating/managing suppliers, of both custom and COTS parts.
Experience in Just-In-Time, Demand Flow Technology, and Lean Manufacturing techniques.

Employment type
Full-time

Work arrangement
No