What are the responsibilities and job description for the Manufacturing Engineer II position at RIVERPOINT MEDICAL LLC?
Riverpoint Medical in Northeast Portland is hiring a Manufacturing Engineer II. At Riverpoint you will be part of the process that brings innovative technology to Medical, Dental and Veterinary markets. We specialize in the design and manufacturing of premium medical devices. Our ingenuity can be found in our suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies. As a full-time Manufacturing Engineer II, you will be responsible for developing, maintaining, and improving production, process methods, support documentation systems, tooling, equipment, and production facility maintenance. This position works closely with the Product Development and Quality Assurance / Regulatory Affairs team to strengthen Riverpoint Medical’s quality system and quality culture. If your passion is to provide hands-on production floor support as well as perform critical thinking analytical work, apply today.
Duties and Responsibilities:
- Leads IQ/OQ/PQ and annual re-validation activities for new and existing front-end processing equipment.
- Drives cost, quality, and technological improvements in key production processes and equipment.
- Creates, maintains, and improves manufacturing process and assembly documentation procedures for employee training, maintaining consistent production and quality performance, and meeting quality system requirements.
- Support operational excellence projects through engineering design, tool validation and implementation of new equipment or process into production.
- Coordinates, directs, and project-manages the design, specification development, cost justification, and vendor selection for equipment purchases, off the shelf, semi-automated, and fully automated.
- Designs jigs and fixtures to support the assembly cells, sterilization, QA, and final product packaging operations.
- Plans, coordinates, and directs the development of new production capacity initiatives to support the company’s business / sales plan. Includes planning and maximizing production area through process improvements.
- Provides work assignment direction and oversight for equipment / facility maintenance staff.
- Assists, reviews, and approves calibration and maintenance records.
- Coordinates and supports QA in implementing relevant area compliance with regards to quality (ISO13485), safety, environmental (ISO 14644), and Riverpoint Medical standard procedures.
- Assists in process investigations of complaints, root cause assessments, nonconformity (NCR), and corrective and preventive action (CAPA) activities.
Education and Qualifications:
- Bachelor’s degree in Manufacturing Engineering, Industrial Engineering, Mechanical Engineering or other related field of study or equivalent work experience
- Minimum 3 years of experience providing direct daily production support in a high-mix, high and low volume, ISO regulated production environment.
- Production support experience supporting a FDA regulated environment is highly desirable, along with an understanding of cGMP, QSR, and ISO 13485.
- Experience with LEAN initiatives and Automation
- Demonstrated computer skills. Preferably in Solidworks, Microsoft Word and Excel at an intermediate to advanced proficiency level. Ability to write Excel VBA macros and / or Microsoft Access or other database software programming skills are desirable.
- Demonstrated technical writing skills.
- Must be able to work in a cleanroom and gown up, lift 35 lbs, and stand on feet for extended periods of time.
We offer great benefits: Medical, Dental and Vision, Life and Accidental Death Insurance; 401(k) with company match and immediate vesting, Paid Time Off and 8 company paid holidays. We also reward our team with bonus pay such as Referral Bonus and Annual Bonus!
Riverpoint Medical is committed to a diverse and inclusive workplace. Riverpoint Medical is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.