Engineering - Senior Process Engineer

Viant Medical; Vega Baja (PR); On-site; USD 90,000 - 125,000; Full time

Job summary

Viant Medical in the United States is seeking an Injection Molding Process Engineer to plan and coordinate equipment setup and processes for high quality molded products. The role supports new program launches, process validation, and continuous improvements while mentoring molding personnel.

The engineer will develop process documentation, provide technical leadership, and collaborate with vendors to resolve equipment issues, ensuring compliance with ISO 13485 and FDA requirements.

Qualifications

• BS degree in Science or related field.
• 5+ years’ relevant experience or 8+ years in medical device or equivalent.
• Experience with 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.
• Strong written/verbal communication skills.
• Training experience to FDA regulations or ISO standards

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.
• 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.

Skills

Process engineering

Project leadership

Molding knowledge

Education

BS degree in Science or related discipline

Tools

SPC

DOE

GR&R

PMEA

IQ/OQ/PQ

FDA/ISO standards

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.

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.