Manufacturing Engineer II

Duties and Responsibilities

• Captures and directs cost / quality improvement efforts for in-house production.
• Develops, 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.
• 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.

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.

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
• Bonus pay such as Retention Bonus, Referral Bonus and Annual Bonus!