Hybrid Sr. Product Release Engineer na Weiss-Aug - All Locations
Weiss-Aug - All Locations · Fairfield, Estados Unidos Da América · Hybrid
- Senior
- Escritório em Fairfield
Description
Join Weiss-Aug – A Leader in Precision Manufacturing and Innovation
Be part of a company that’s shaping the future of manufacturing where your ideas, skills, and passion matter.
Weiss-Aug, is a leading provider of advanced manufacturing and engineering solutions with advanced facilities across the U.S. and Mexico for over 50 years.
Why Join Us?
At Weiss-Aug we are driven by a commitment to excellence, innovation, and continuous improvement. As a recognized leader in the industrial and commercial sectors, specializing in high-volume metal stamping, thermoplastic molding, and value-added assembly solutions our Weiss-Aug MedPharma serves the medical device and life science industry, offering unparalleled vertically integrated manufacturing solutions, partnered with in-house product design and engineering services. These combined capabilities provide Weiss-Aug a strategic advantage over the competition, being able to offer our customers a true, single-source supplier option, to meet their most challenging product innovation needs.
As we continue to push the boundaries of what is possible, including our latest advancements in materials science, specialty coatings, laser processing, and hybrid additive manufacturing technologies – Weiss-Aug MedPharma needs the best minds in industry. Expanding our team is paramount, bringing in fresh perspectives, ideas and broad-based talent to further enhance our solution offerings, driving new growth and supporting our technology roadmap – including the release of finished drug-delivery / combination devices and machined implants.
We're currently seeking a passionate and skilled Sr. Product Release Engineer to join our team and contribute to our mission of delivering high-quality, engineered solutions to our customers worldwide. In this role you will be responsible for designing, developing, testing, and evaluating products. They use their knowledge of engineering principles and technology to develop new products, improve existing products, and ensure that design specifications are met.
Responsibilities:
- Oversee all aspects of programs from concept definition through successful transfer to manufacturing, advocate for the customer and needs/requirements.
- Provide leadership to cross-functional technical teams responsible for successful launch of multiple complex programs.
- Responsible for overseeing the coordination and on-time/in-budget completion of all project tasks which may involve some or all of the following technologies: progressive stamping, insert molding, factory automation and other related tooling/processes.
- Oversee the creation and distribution of project schedules. Ensure that project milestones and deadlines are met including assignment of responsibilities.
- Facilitate design definition, design reviews, tooling kickoff, and project postmortem activities.
- Understand and meet Regulatory (FDA) requirements and processes for development.
- Advanced Product Quality Planning (APQP) including completion of related documentation, including but not limited to: DOE’s, FMEA’s, Process Flowcharts, Control Plans, Capability Studies and Gage R&R’s.
- Oversee the creation of BOMs and initiation of the change control process (ECO) relating to Engineering documentation.
- Jointly responsible for successful transfer of tooling to Manufacturing along with Tooling and Design Engineering functions.
- Oversee the selection and management of key suppliers and the completion of requisitions for purchased tooling or other product or services. Interface with outside suppliers to ensure they provide product or services on-time and to specifications.
- Assist in determining needs for additional personnel and/or training in order to meet program needs.
- Identify and facilitate addition of personnel, training, and special equipment needs to support project success.
- Interface with customer on technical and schedule-related issues, ensure program progress is communicated to customer at regular intervals.
- Participate in customer, internal, regulatory, and quality system audits.
- Support Sales as needed to assist in identifying potential leads and opportunities
Requirements
- Minimum of a bachelor’s degree in mechanical engineering or biomedical engineering
- Minimum of 10 years of medical device or life science industry experience, preferably in a product development engineering position.
- Experience in developing and implementing procedures, methods, and tools for the manufacture or design and testing of medical products.
- Experience in contributing to technical and cross-functional teams in accomplishing projects with notable impact(s) on company objectives.
- Experience in Regulatory (FDA) requirements and processes for development.
Pay Range: $30-$35 per hour plus 15% shift differential
Other Benefits Include
- Medical, Dental and Vision
- 401 (k) with company match
- Holiday, Vacation and Sick Time
- Tuition Reimbursement
- Health Savings Accounts (HAS)
- Flexible Spending Accounts (FSA)
- Cigna Wellness Incentive Program
- Employee Assistance Program (EAP)
- Short Term Disability
- Group Life and Accidental Insurance
- Sun Life – Accident, Critical Illness, and Hospital Indemnity Insurance
- Smoking Cessation Program
- Pet Insurance
US Pay TransparencyThe base salary for this role will be determined on a case-by-case basis and may vary based on the following considerations: job-related knowledge and skills, experience, and internal consistency.
If your salary requirements exceed the advertised range and you remain interested in Weiss-Aug, we encourage you to apply.
Weiss-Aug is an Equal Opportunity/Affirmative Action Employer. Applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other characteristics protected by applicable federal, state, or local law.