Job description

Are you passionate about being part of a Team that will become the most trusted medical device molding and assembly service provider?

Purpose: The Sr. Process Engineer will have the opportunity work with the Engineering team to implement improved robust operating systems, processes, efficiencies and quality utilizing KPI trending and data driven decisions that will strengthen and grow your team, operations and our business as a whole. This poerson will also provide major input into the design, development, and implementation of processes for new products and processes.
This role can be remote based with frequent travel to Westfield, PA site along with Chicopee, MA and South Plainfield, NJ sites.

Innovation: Be a part of selecting and implementing new injection molding presses, automation, molds and support equipment with a commitment to annual capital equipment spend. Work with other Viant Medical sites and engineering teams to benchmark successes and share best practices.

Vision: Our focus is on enhancing the customer experience by building true business partnerships and our business though, Teamwork, Being Agile, having Personal Integrity, Owning It and Recognizing the Success of others because Together We Are In It For Life.

MAIN JOB RESPONSIBILITIES
This position is responsible for providing sustaining engineering support for all existing processes and production with hands on problem solving techniques. This position will also provide major input into the design, development, and implementation of processes for new products and processes.

• Follow all Good Manufacturing Practices (GMP's) as defined by Viant’s practices, policies and Standard Operating Procedures (SOP's) to insure that FDA regulations are met.
• Focus on daily customer and process related issues to improve quality, on time delivery and process efficiencies. Implement corrective actions where appropriate.
• Plan, lead, execute and complete projects to improve productivity and quality through proper investigation and data driven six sigma principals.
• Provide Scientific Molding Analysis by:
• Identify optimal conditions by evaluating factors such as material temperature, flow rate, pressure, and cooling rate during molding process and most important during the development of molding process.
• Design plastics or injection-mold fabrication processes.
• Create and improve injection-mold machinery.
• Develop molding process manufacturing processes.
• Analyze manufacturing data and suggest improvements.
• Analyze production and machinery line.
• Ensure quality output of molded components.
• Develop and design engineered plastic parts, insert molded parts and assemblies.
• Establish the parameters for an optimal molding environment.
• Analyze quality control and correct flaws.
• Review existing validation reports.
• Create new reports and verifications.
• Analyze mold flow, part advisor analysis, finite element analysis, and stress/fatigue analysis on plastics.
• Provide Engineering support for all manufacturing Kaizen events.
• Support and develop validation protocols and reports (I0/00/PQ) and provide objective evidence that equipment, processes, test methods and product meet requirements and are complaint with applicable regulations.
• Close communication with customers, QA, suppliers and product development teams on project matters, material issues, tooling and fixture design, process capability studies, and product quality issues for existing processes, products and related projects.
• Design and procure process tooling
• Develop process documentation and training materials for new processes, materials, and equipment, including drawings, protocols, completion reports and specifications.
• Conduct research and development testing and validation to determine effectiveness and compliance to quality standards for the manufacturing processes. Confirm conformance to engineering designs and methodologies and verify overall safety. Prepare reports on these activities.
• Utilize proven lean manufacturing based analytical and troubleshooting/problem solving abilities to identify opportunities for cost reduction, lead-time reduction, inventory reduction and quality improvement through defect reduction.
• Supervisor Processing and Mold Set Up Technicians, set priorities for the day, troubleshoot and manage any personnel or mold issues.

REQUIREMENTS

• Bachelor's Degree in Engineering; preferably in plastics engineering, polymer science or materials science.
• Minimum 5 years experience working as a process engineer with previous experience in medical devices
• Previous experience or training with project management techniques.
• Technical experience in silicone rubber & (LSR) or plastic processing.
• Experience with Scientific Injection Molding Principles in a related manufacturing environment.
• Experience with automation, robotics, PLCs and inspection systems
• Demonstrated oral and written/technical document creation and presentation skills.
• Familiarity with statistical problem solving and six sigma techniques.
• Experience with validation protocols and reports, DOE, FMEA risk assessments, technical report authoring, strong statistical data analysis.
• Attention to detail and able to work independently and on a team with little supervision.
• CAD proficient in 2D dimensioning and tolerance.

#INDHP

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 viantmedical.com 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.

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