Senior Manufacturing Engineer
POSITION ACCOUNTABILITY (Position Reports To)
Position reports to Engineering Group Leader/Manager/Director.
POSITION DESCRIPTION / RESPONSIBILITIES
Develops, implements, and improves new and existing manufacturing processes for medical device products. Provides engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with company’s procedures. Supports current production, providing technical solutions to meet quality, safety, cost, and efficiency goals. Supports Continuous Improvement initiatives. Position will be assigned either to the New Product Introduction Group or the Sustaining Engineering Group as required, while also supporting projects related to the greater team and company effort.
May assume a team lead role for the work group. May have primary responsibility for projects of any size and complexity, requiring guidance only on unusual or complex problems. Provides technical guidance and acts as a role model to less senior engineers working on a project. Makes decisions within the scope of the project based upon analysis as well as the recommendations of others. Regularly makes decisions relating to process approaches after reviewing various alternatives. Seeks any required approvals after presenting proper justification. Work is highly independent.
- Participates in multifunctional teams, led by a Program Manager and is responsible for defined project deliverables.
- Supports the development of costing for new products by calculating production, labor, and material costs. Performs make vs buy analysis and capital equipment justifications.
- Develops and maintains manufacturing documentation for products, to include ERP system setup, Component Drawings and Specifications, Inspection Plans, Bill of Material and Routing, Assembly and Packaging Drawings, Standard Operating Procedures (SOPs), Work Instructions, Quality Plans, and other required documents. Ensures that all documentation is generated in compliance with company quality system procedures and customer requirements.
- Manages changes to products through the ECO process, from creation to final approval.
- Supports supplier selection and sourcing of parts, materials and equipment. Works closely with suppliers to ensure design requirements are adequately defined and met. Creates First Article Inspection (FAI) plans.
- Executes process and equipment validations, including IQ, OQ, & PQ and Test Method Validation (TMV), performs data analysis on results, and authors protocols/reports. Maintains the Validation Master Plan.
- Develops process flow, assembly line layout, assembly work standards, and designs fixtures to ensure high quality and repeatable production of parts.
- Leads Process Failure Modes and Effects Analysis (PFMEA) for products and generates strategies for reducing overall process risk.
- Supports Operations Department in assuring that assembly lines meet company’s manufacturing standards. Performs process troubleshooting and provides practical solutions. Trains or provides work direction to operators. Keeps abreast of operations KPIs.
- Acts as the customer-facing technical representative from Viant for assigned products. Leads and/or attends customer meetings. Prioritizes the resolution of customer issues and requests.
- Leads investigation on part nonconformities, customer complaints and Corrective & Prevention Action (CAPA).
- Supports Operational Excellence program. Uses Lean Six Sigma methods to design and improve processes.
- Plans and organizes tasks to complete a project involving other technical personnel on time. Achieves complex project goals by effectively utilizing expertise/resources. Provides accurate status of project schedule and results.
- Adheres to and verifies conformance to job procedures, GMP and safety procedures. Assesses whether necessary specifications and standards exist, are appropriate and/or are being followed.
- Keeps abreast of new/developing technologies and trends within medical device manufacturing.
- May include other duties as defined by the Department Manager.
SKILLS AND COMPETENCIES
- Exudes values of being customer-centric, accountable, collaborative, and respectful and demonstrates active listening. Driven, with a sense of urgency. Self-motivated, with a strong desire to learn and improve self.
- Excellent attention to detail and accuracy. Establishes and maintains high standards for quality and considers excellence a fundamental priority.
- Applies modern principles of time and project management to plan and achieve goals.
- Ability to successfully explain ideas to all levels of personnel and can condense technical topics into the critical facts and issues for discussion. Ability to provide justification to support technical position. Ability to independently define, prepare and present technical topics for group presentation, or for training purposes.
- Capable of assessing one’s technical capabilities and effectively providing hiring supervisor with feedback.
- Excellent analytical, technical and troubleshooting skills. Hands-on approach to problem solving.
- Demonstrated understanding and application of modern manufacturing principles and methods to a medical device manufacturing operation
- Demonstrated experience using Lean Six Sigma principles to improve a process with measurable results.
- Demonstrated proficiency with ERP systems and ECO processes.
- Demonstrated proficiency with IQ, OQ, PQ Validation Strategies and Test Method Validation / Gauge R&R.
- Demonstrated understanding of GMP, ISO 13485, and ISO 14971.
- Demonstrated understanding and application of Quality tools such as ‘Define, Measure, Analyze, Improve, Control’ (DMAIC), ‘Failure Modes & Effects Analysis’ (FMEA), ‘Design of Experiments’ (DOE), Gage Repeatability & Reproducibility’ (Gage R&R) and ‘Statistical Process Control’ (SPC) as required.
- Demonstrated proficiency with AutoCAD and SolidWorks. Should be capable of developing 2D drawings, manipulating 3D assemblies and modeling complex fixtures and gages.
- Demonstrated proficiency with Microsoft Outlook, Microsoft Project, Microsoft Visio and Microsoft Office applications
- Light physical activity performing non-strenuous, day-to-day activities of a primarily administrative nature.
- Moderate lifting (20 lbs), carrying (10 lbs), bending, and prolonged sitting.
- Requires the ability to identify and distinguish colors.
- Requires the ability to judge distance and space relationships (i.e. visualize objects of multiple dimensions).
- Well-lighted, air-conditioned, indoor laboratory/production setting with adequate ventilation.
Office Equipment, common power and hand tools, measurement devices, and basic electrical devices.
- Bachelor’s Degree in Engineering, with 10-15 years of professional experience in an engineering role, with at least 4 years of experience in medium/high volume assembly manufacturing environment.
- Experience working in highly regulated industries, with knowledge of ISO 13485, GMP and FDA.
- Hands on experience in manufacturing process development, ERP Systems, SolidWorks/AutoCAD, PFMEA, and writing and executing IQ/OQ/PQ Protocols.
- Experience with the generation, release, and change control of various document types.
- Master’s Degree in Engineering. Manufacturing, Industrial, or Mechanical Engineering disciplines preferred.
- Engineer in Training (EIT) Certification.
- Project Management Professional (PMP) Certification.
- Certified Lean Six Sigma Green Belt.
At Viant, we focus on providing end-to-end solutions for medical device OEMs. Our deep materials expertise—combined with our experience in engineering, manufacturing, assembly, packaging, and sterilization—allows us to bring our customers’ healthcare solutions to market. We have facilities across the U.S. and around the world, including low-cost facilities in Costa Rica, China, Mexico, and Puerto Rico.
Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.