Job Description
Position Purpose: This is a “hands on” engineering position responsible for leading the development, installation, validation, ramp-up, and life cycle management of injection molds and molding solutions for medical device components.
KEY RESPONSIBILITIES/ESSENTIAL FUNCTIONS:
- Responsible for preparing tooling specifications for supporting requests for quotes and supporting vendor selection activities including the analysis of mold design/build costs.
- Responsible for ensuring that injection molds can produce parts that meet customer requirements while providing for internal manufacturing robustness.
- Coordinate implementation of cost-effective mold design changes.
- Collaborate with internal and external team members in completing mold qualification activities (DQ/FAT/IQ/OQ/PQ).
- Ensure that cost, quality, timelines, and internal & external customer expectations are managed appropriately.
- Perform Design for Manufacturability reviews with the mold supplier and customer
- Coordinate tool repair and refurbishment activities as needed.
- Investigate and benchmark new tooling, peripherals, and molding technologies
- Support tool maintenance to investigate and fix major issues on existing tools. Consultant on complex tooling issues.
- Track equipment performance metrics and manage ramp-up action plan to achieve operational performance targets.
- Seek feedback from the floor on what works / doesn’t work and develop improvement action plans
- Ensure compliance with industry standards and corporate engineering guidelines.
- Serve as Subject Matter Expect supporting general business needs as required.
- Lead root cause investigations and corrective action implementation.
- Support lean and continuous improvement initiatives.
- Follow all safety procedures including the use of Personal Protective Equipment as required.
- Other duties as assigned
POSITION REQUIREMENTS:
- Bachelors Degree in Engineering, Technical degree or equivalent experience
- Industrial manufacturing experience working in high-volume injection molding
- 5+ years of related experience
- Experience in the qualification of complex, and tight tolerance injection molding
PREFERRED KNOWLEDGE/SKILLS:
- Must have clear and well organized oral and written communication
- Knowledge of statistical methods (Six Sigma, SPC, DoE)
- Excellent problem-solving skills using DMAIC methodology
- Experience working in a cGMP / ISO 13485 compliant manufacturing environment
- Mold Maker Certification or similar a plus
WORK ENVIRONMENT:
Works in an office and clean manufacturing environment that may include moderate noise levels and required appropriate PPE and cleanroom apparel
Occasional travel up to 15% based on assignments
Qualifications
- Bachelors Degree in Engineering, Technical degree or equivalent experience
- Industrial manufacturing experience working in high-volume injection molding
- 5+ years of related experience
- Experience in the qualification of complex, and tight tolerance injection molding
Additional Information
All your information will be kept confidential according to EEO guidelines.
PAY RANGE: $100,000 - $130,000 (USD Salaried)
For US Benefits, CLICK HERE.
Nemera is an equal opportunity employer and does not discriminate against any person on the basis of race, religion, color, gender, gender identity, sexual orientation, age, national origin, disability, veteran status, or any other protected class indication. This company is required by federal law to hire only persons who can establish they are eligible to work in the United States.
Top Skills
What We Do
As a world-leading drug device combination solutions specialist, our purpose of putting patients first enables us to design and manufacture devices that maximize treatment efficacy. We are the utmost holistic partner and help our customers succeed in the sprint to market. From early device strategy to state-of-the-art manufacturing, we're committed to the highest quality standards. Agile and open-minded, we work with our customers as colleagues. Together, we go the extra mile to fulfill our mission.
Nemera’s services and products cover five key delivery routes:
● Ophthalmic (preservative-free multidose eyedroppers)
● Nasal, Buccal, Auricular (pumps, valves and actuators for sprays),
● Inhalation (pMDI, DPIs)
● Dermal and Transdermal (airless & atmospheric dispensers)
● Parenteral (auto-injectors, pens, safety devices & implanters)
At Nemera, we put patients first when designing, developing and manufacturing drug delivery devices because we know that accurate dosing and ergonomics contribute to patients completing their treatment. Whether they are Nemera proprietary or customer owned, our devices receive the utmost care because we know how critical they are for patients’ health and well-being.
Interested in joining a team that truly enjoys working together and prides itself on being at the forefront of innovation and quality? Do you always go the extra mile to deliver on your commitments? Want to feel proud of your work because it improves patients’ lives?
If you're ready to help us grow our business and make a real difference, please visit https://www.nemera.net or contact us at [email protected].