Engineering - Senior Manufacturing Engineer

JOB SUMMARY:

Senior Manufacturing Engineer leads initiatives for the daily support of production lines, manufacturing processes, materials, and equipment to meet the performance goals (i.e., safety, quality, cost, and delivery). The primary role involves the plastics injection molding, sub-assembly and assembly processes. Will work in a fast-paced and dynamic environment; this position will be responsible for several manufacturing processes, working cross-functionally with quality and production teams to achieve goals. Will manage manufacturing areas KPIs from data gathering to reporting progress and status on value improvement projects as needed. Is responsible for leading integration of new products within production, meeting new product integration timelines and production goals (i.e., safety, quality, delivery, cost, and productivity). This individual will be required to collaborate with cross-functional and cross-site teams to evaluate, troubleshoot and implement manufacturing processes within the business unit. Works with operational excellence to develop value added ideas, support proper implementation and control them thru sustaining approaches. Will support on any given task related to manufacturing process, equipment and/or personal directly influencing production.

RESPONSIBILITIES:

• Provides support of production, processes, materials and equipment to achieve department goals (i.e. safety, quality, delivery, and cost).
• Works cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain, and Marketing on complex projects to ensure project success.
• Successfully completes complex engineering work and contributes to new product development teams and product support, typically including the following activities: technology development, test of materials or products, preparation of specifications, Six Sigma, process study, process improvements, and report preparation.
• Performs equipment qualification, process validation, and test method validation activities
• Designs and prepares engineering reports and communicates results to the technical and leadership audiences.
• Perform DOE processing runs to support FDA process validation procedures.
• Designs and coordinates applicable engineering tests and experiments.
• Performs troubleshooting on new and existing products/process problems as related to design, material, or processes.
• Summarizes, analyzes, and draws conclusions from complex test results.
• Applies problem solving and process improvement methodologies to improve complex and diverse manufacturing processes across multiple product lines, ensuring root cause of problem is identified and quickly resolved.
• Prepares standard reports/documents to communicate results to the technical community.
• Will manage manufacturing areas KPIs from data gathering to reporting progress and status on value improvement projects as needed.
• May lead cross-functional project teams.
• Will perform "gemba" walks to audit machine and operator related processes.
• Identifies, implements, and manages equipment requirements to support production goals.
• Trains and/or provides work direction to operators/technicians.
• Consistently generates innovative and unique solutions to complex problems of diverse scope to meet department goals.
• Ensures that new products introduced to the production floor meet business, quality, output and cost goals and objectives
• Selects process improvement techniques to solve technical problems and makes sound equipment and process recommendations. Has a broad knowledge of a variety of alternatives and their impact on the business unit.
• Coordinates, manages, and documents project goals and progress and recommends appropriate revisions.
• Assesses the feasibility and soundness of proposed engineering evaluation tests, products, or equipment.
• Works with operational excellence to develop value added ideas, support proper implementation and control them thru sustaining approaches.
• Completes and manages Capital Equipment Request Authorizations (CERA's).
• Leads cross-functional project teams.
• Leads in the identification, implementation, and management of Business Unit goals and actively contributes to development of Business Unit's multi-year strategy.
• Capable of training team members, including engineers, technicians, and product builders on specific tasks. Participates in the development of junior staff by setting an example, providing guidance, and offering counsel.
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

POSITION REQUIREMENTS:

• Bachelor's Degree in Engineering discipline required, Master's Degree preferred
• 5+ years of manufacturing, process or related engineering experience in medical device or highly regulated industry
• Experience solving advanced technical problems
• Experience qualifying complex equipment
• Lean manufacturing experience
• Experience managing multiple projects simultaneously
• Strong bias for action and ability to effectively prioritize work and deliver business results in a fast-paced, constantly changing environment are critical
• Practical understanding of manufacturing problem solving and process improvement tools such as DMAIC and production flow tools such as LEAN manufacturing

LEADERSHIP RESPONSIBILITY:

Leads technicians, engineers & cross-functional leaders. Direct or indirect people leadership experience and managing projects preferred

Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit or follow us on LinkedIn.

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.