Engineering - Senior Process Engineer

Viant Medical Inc.; Vega Baja (PR); On-site; USD 85,000 - 115,000; Full time

Job summary

Viant Medical Inc. seeks an experienced Process Engineer to develop and document new and existing manufacturing processes for medical devices.

You will assess processes, implement improvements for quality, productivity, and equipment efficiency, and provide technical leadership to molding personnel. You will collaborate with vendors and cross-functional teams, maintain process documentation, and apply statistical methods to meet cost, quality, and delivery goals.

Qualifications

• BS degree in Science or related discipline.
• 5+ years of relevant experience, or 8+ years in medical device or equivalent.
• Experience with SPC, DOE, GR&R, PMEA, and process validation (IQ, OQ, PQ).
• Knowledge of FDA and ISO/MDD standards.
• Leading projects and mentoring engineering teams.
• Strong communication and teamwork skills.

Responsibilities

• Develop and document new and existing processes to improve quality and productivity.
• Provide technical leadership to process technicians, operators and molding personnel.
• Create process documentation such as process sheets and validation documents.
• Support manufacturing with process control improvements and cost-reduction initiatives.
• Ensure regulatory compliance with FDA and ISO standards on the production floor.
• Lead continuous improvement projects across functions.

Skills

Statistical Process Control

DOE

GR&R

PMEA

Process Validation

FDA & ISO Standards

Education

BS in Science or related discipline

Job description

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 (e.g., process sheets and validation documentation).
• Provide technical support/solutions to manufacturing processes, improve yield and throughput, drive cost‑reduction activities, and improve part quality from a process standpoint.
• Demonstrate ability to start‑up, operate and shut down process‑related equipment.
• Work independently on new process development as well as troubleshoot current production issues.
• Collaborate with equipment and material vendors to resolve machine and material issues.
• Monitor and report issues with injection molds, making recommendations for refurbishment based on 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 ongoing 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.
• Support quality disciplines, decisions and practices from the manufacturing process standpoint.
• Maintain compliance with the Quality Policy and all other documented quality processes and procedures, demonstrating a primary commitment to patient safety and product quality.
• Provide feedback in championing departmental or cross‑functional engineering initiatives.
• Provide project direction, coaching and mentoring for engineering and technical team personnel as well as direct reports if applicable.
• Proactively investigate, identify and implement best‑in‑class process engineering practices.
• Establish effective corrective action plans for process‑related issues.
• Act as an effective leader or team member in supporting quality process disciplines, decisions and practices on the production floor.
• Apply 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.
• Ensure company regulatory, FDA and ISO compliance in all areas of responsibility.
• Provide technical supervision and guidance to personnel.
• Comply with requirements of ISO 13485 and company Environmental, Health and Safety standards and follow related procedures and instructions.

Position Requirements

• BS degree in Science or related discipline.
• 5+ years of relevant experience, or 8+ years in medical device or equivalent.
• Demonstrated knowledge of 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.
• Strong interpersonal skills with ability to work within a team environment.
• Strong written and verbal communication skills.
• Training experience with FDA regulations or ISO standards.
• Preferred: Six Sigma problem‑solving methodologies and/or ASQ certification.

Leadership Responsibility

Leads technical and engineering and 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.

Equal Employment Opportunity

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.