Mfg Indirect - Assembly Combo - Production Lead

Viant Medical Inc.; Vega Baja (PR); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, and vision

Shift differential pay

401k with company match

Paid time off

10 paid holidays per year

Referral bonus

Company-paid life insurance

On-site training

Career path for advancement

New hire onboarding training

Job summary

Viant Puerto Rico is seeking a Production Leader for the 2nd shift to oversee combo assembly, ensure products meet specifications, and drive continuous improvement within GMP guidelines.

You will generate production reports, manage ERP transactions, and support a Lean, kanban-based workflow while adhering to company policies and safety protocols.

Qualifications

• Bachelor's degree in engineering, business, or technology-related fields.
• Minimum 1 year of manufacturing experience in medical device or pharmaceutical industries.
• Experience with GMP/quality systems and documentation practices.

Responsibilities

• Operate in the assigned combo assembly area on a daily basis.
• Follow GMP procedures and quality standards.
• Execute production reports and ERP system transactions.
• Maintain one-piece flow and 5S activities in the area.

Skills

Process improvement

RCA

FMEA

SPC

Lean manufacturing

Six Sigma

Quality systems

Data analysis

Documentation

Equipment validation

Process optimization

Education

Bachelor's degree in Engineering, Business Administration, Technology & Computer

Tools

IQMS

ERP System

Job description

Production Leader

Join a team dedicated to creating life-enhancing medical devices that improve lives around the world. Whether you're starting your career or bringing prior experience, Viant offers opportunities to learn, grow, and make a meaningful impact. Through our people-first culture and commitment to We're In It For Life, we support your development, well-being, and long-term success.

Compensation:

We offer market competitive compensation and Career Laddering Opportunities. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

Work Schedule:

We are expanding and have the following shift available:

2nd Shift.

Benefits:

• Medical, dental, and vision benefits-effective on date of hire!
• Shift differential pay
• 401k plan with company match
• Generous paid time off benefits and 10 paid Holidays per calendar year
• Referral Bonus
• Company-paid life insurance
• On-site Training Programs
• Defined Career Path for advancement in role and compensation
• New Hire On-boarding Training Plans

About the role:

The Production Leader will perform assigned duties at combo assembly stations to make sure products comply with specifications. Perform Production Reports / production transaction at the end of shift and any other requirement with ERP System. In the event of absence, another trained Combo Assembly lead will assume duties. The employee wilI also follow all GMP (Good Manufacturing Practices) rules and procedures pertaining this job as outlined in the training program.

Job Responsibilities:

• Work in assigned combo assembly area on daily basis.
• Understands and follows Good Manufacturing Process (GMP) Procedures.
• Execute Report and Disposition ERP System.
• Understands and follow One Piece Flow and 5's systems.
• Understand and Run Kan Ban system for inventory parts in combo assembly area. As required.
• Make sure production complies with specifications for quality requirements.
• Notifies Supervisors if any problems arise with product.
• Ensures correct packaging of product.
• Fill out paperwork related to the combo assembly assignments, including auxiliar equipment data. As required.
• Performs any work-related duty assigned by Supervisor.
• Follow safety policies and procedures.
• Flexibility to possible extensions in schedules.
• Live Viant core values.

Job Requirements:

Education:

• Bachelor's of Science in Engineering ,Business Administration, Technology & Computer.

Experience:

• One year experience in Manufacturing Industry (Medical Device Related) or Pharmaceutical Industry.
• Support validation process of New Product Development.

Skills/Competencies:

• Process improvement
• Root Cause Analysis (RCA)
• Failure Mode and Effects Analysis (FMEA)
• Statistical Process Control (SPC)
• Lean Manufacturing
• Six Sigma methodologies
• Quality systems (ISO 9001, AS9100, GMP)
• Data analysis and reporting IQMS
• Technical documentation MASTER CONTROLRisk assessment
• Equipment validation and qualification
• Manufacturing process optimization

Physical Requirements:

• Regularly required to stand, walk, stop, kneel, crouch, and use hands to finger, handle or free objects.
• Use of common hand tools and occasionally sharp tools are involved.
• Frequently move and/or lift objects up to 50 pounds.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and depth perception. (Note: All employees must wear company approved safety glasses while in the manufacturing area).

About the site:

At Viant Puerto Rico, every product begins with a disciplined approach toprocess. The team's expertise in drug delivery and complex device assembly allows for precise, repeatable performance at scale and the control needed to meet the most demanding regulatory and clinical requirements.

The facilitysupportssterile and non-sterile medical devices across a range of clinical applications. Flexible supply models (make-to-order, Kanban, vendor-managed inventory, and consignment) allow customers to scale production without interruption, too.

About the company:

Viant is a global medical device partner providing design, development, manufacturing, and assembly services through capabilities in materials, plastics, metals, extrusion, and automation. With nearly 6,000 employees across 24 locations worldwide, it delivers high-quality, life-enhancing products with the scale and expertise to bring devices to market efficiently. Learn more at Viant Medical's website or in LinkedIn.