Engineering - Senior Process Engineer

Viant Medical Inc.; Vega Baja (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Viant Medical Inc. seeks an Injection Molding Process Engineer to plan, coordinate equipment setup and processes for high-quality molded products.

You will support new program launches, develop processes, and mentor molding staff while delivering data-driven improvements and training. The role emphasizes independent development, troubleshooting, and collaboration with suppliers and customers to meet cost, quality and delivery goals, all while maintaining regulatory compliance on the production

Qualifications

• BS degree in Science or related discipline required.
• 5+ years' relevant experience in medical device manufacturing.
• Knowledge of SPC, DOE, GR&R, PMEA and process validation (IQ/OQ/PQ) with FDA/ISO standards.

Responsibilities

• Develop and document new injection molding processes and improvements.
• Lead technical mentoring for molding personnel.
• Ensure process documentation and regulatory compliance (FDA/ISO).
• Support cost reduction, yield improvements and product quality.

Skills

SPC

DOE

GR&R

PMEA

Process validation

FDA/ISO standards

Education

BS degree in Science or related discipline

Tools

Six Sigma

Job description

The Injection Molding Process Engineer is a "hands-on" position that plans and coordinates manufacturing equipment setup and processes to produce high quality injection molded product. The Process Engineer is responsible for supporting the molding efforts on new program launches, setting up and/or revising manufacturing processes and assisting the manufacturing operations in problem solving and continuous process improvements. While monitoring the effectiveness of processes this individual quantifies results, documents and presents findings to management and prepares reports if required. This position also mentors and provides training to other injection molding personnel.

RESPONSIBILITIES:

• Develop new processes, assess and document new and existing processes.
• Implement and evaluate changes to existing processes designed to improve product quality, productivity and overall equipment efficiency.
• Provide technical leadership and mentorship to process technicians, operators and other molding personnel.
• Develop and maintain process documentation ensuring that processes and procedures are clearly stated and understandable for all employees. i.e Process sheets and/or validation documentation.
• Provide technical support/solutions to manufacturing processes, improve yield and throughput, drive cost reduction activities and improve on part quality from process standpoint.
• Demonstrated ability to start-up, operate and shut down process related equipment.
• Must be able to work independently on new process development as well as troubleshooting current production issues.
• Work with equipment and material vendors to resolve machine and material issues.
• Monitor and report issues with injection molds, make recommendations for refurbishment based on production factors such as cycles, process capability and tooling history.
• Interact with customers to resolve issues and provide new project updates.
• Implement technical solutions including statistical methodology to meet customer cost, quality, and delivery expectations.
• Facilitate and support facility and manufacturing safety, environmental, and ergonomics efforts.
• Provide direct support to on-going manufacturing of products by identifying and implementing effective process control systems that meet or exceed internal and external requirements.
• Identify and drive continuous improvement projects and quality initiatives by collaborating and communicating effectively with various functions.
• Supports quality disciplines, decisions, and practices from the mfg process standpoint.
• 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.
• Provides feedback in championing departmental or cross-functional engineering initiatives.
• Provides project direction, coaching, and mentoring for engineering and technical team personnel as well as direct reports if applicable.
• Proactively investigates, identifies, and implements best-in-class process engineering practices.
• Establish effective corrective action plans for process related issues.
• Acts as an effective leader or team member in supporting quality process disciplines, decisions, and practices in the production floor.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving process issues, including PMEA.
• Generate internal quality documentation such as process sheets, scientific injection molding phases and any other standard operating procedures deemed applicable to its responsibilities.
• Ensure company regulatory, FDA and ISO compliance in all areas of responsibilities.
• Able to supervise technical personnel and provide guidance.
• Must comply with requirements of ISO 13485 and company Environmental, Health and Safety standards and follow procedures and instructions related to these standards.

POSITION REQUIREMENTS:

• BS degree in Science or related discipline.
• 5+ years’ relevant experience and or 8+ years in medical device or equivalent.
• Demonstrated knowledge on tools/methodologies including SPC, DOE, GR&R, PMEA, process validation (IQ, OQ, PQ) and FDA, ISO/MDD standards.
• Experience leading projects, coaching, and mentoring for engineering and technical team personnel.
• Demonstrated interpersonal skills with ability to work within a team environment.
• Strong written/verbal communication skills.
• Training experience to FDA regulations or ISO standards
• Preferred Qualifications: Six Sigma problem solving methodologies, and/or ASQ certification..

LEADERSHIP RESPONSIBILITY:

Leads technical and engs & cross functional leaders

OTHER:

The role is required to be 100% onsite with occasional travel as deemed necessary.

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not limited to be constructed as an exhaustive list of all responsibilities, duties and skills required of employee assigned to this position.