Manufacturing Engineer II
Riverpoint Medical Portland, OR
- Posted: over a month ago
Riverpoint Medical is hiring a Manufacturing Engineer II
Riverpoint Medical, Portland, OR. founded in 2008, is a fast-paced growing organization that designs, develops, and markets next-generation medical devices for the Veterinary and Human Healthcare markets.
Title: Manufacturing Engineer II
Reports To: Director, Manufacturing Engineering
The Manufacturing Engineer position is responsible for developing, maintaining, and improving
production, process methods, support documentation systems, tooling, equipment and production facility maintenance. This position works closely with the Quality Assurance / Regulatory Affairs
Department 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, this job may be for you.
Duties and Responsibilities:
- Coordinates and directs the development of cost / quality improvement efforts for in-house production.
- Creates, maintains, and improves manufacturing process and assembly documentation procedures for employee training, maintaining consistent production and quality performance, and meeting quality system requirements.
- 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 and cell layouts.
- Plans, coordinates and directs the company’s preventive and predictive maintenance program including the analysis, tracking, and recommendations for equipment / facility repair and maintenance projects.
- 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 and supports in performing supplier audits and supplier improvement initiatives.
- 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 preferred
- 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
- Must have 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
- Machine shop experience and /or ability to operate a manual/CNC mill and lathe is desirable.
- Must be able to work in a cleanroom and gown up, lift 35 lbs, and stand on feet for extended periods of time.
- Generous health (medical, dental and vision) package with options
- 401k Matching
- Paid Time Off including 7 paid holidays
- Life, Long Term Disability and AD&D
- Wellness Programs
- Annual Bonus and Merit increases
- Referral Bonus
- Retention Bonus
Based in Portland, Oregon, Riverpoint is a major developer and manufacturer of advanced bioabsorbable and non-absorbable sutures, high-strength fiber implantables for sports medicine surgery, patented cordless surgeon headlights, and brachytherapy oncology devices. Riverpoint markets products into orthopedic, spine, neuro, cardio-vascular, women’s health and other surgical markets. With exacting product quality and customer service standards and a highly-efficient R&D and production facility, Riverpoint is a major provider of suture products into veterinary and dental sectors. Its products are sold worldwide on a branded, private label and OEM basis and major medtech companies rely on Riverpoint for its innovative offerings serving into high growth, highly technical, and high margin areas. At Riverpoint Medical we continue to build our business model around exceeding customer expectations and demands while in turn facilitating excellent surgical outcomes.
At Riverpoint Medical, we are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status and any other characteristics protected by applicable law. We embrace and celebrate diversity and think hiring people with a variety of backgrounds, perspectives and skills makes our work even better.
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