Job SummaryThe Engineer II in Injection Molding supports the design, development, validation, and production of precision injection molded components used in medical devices. This role is responsible for investigating, planning, and implementing improvements in and/or additions to current products and manufacturing processes that enhance safety, quality, regulatory compliance, and operational efficiency. Working closely with Product Development, Production, Quality, and external suppliers, the Engineer II optimizes mold designs, processing parameters, and production performance while ensuring compliance with applicable regulatory and quality requirements. This position may also lead engineering projects and contribute to initiatives requiring collaboration across multiple disciplines.
This position is on-site in Elkton, MD.
Job Details/Responsibilities1. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
2. Provide technical assistance to plan and implement specified projects to be completed including organizing and leading projects of various departments, planning and scheduling, coordinating resources (personnel, materials, time, money, suppliers), preparing proper documentation, etc.
3. Assist with cause-identification and problem-resolution for various types of production or service-related issues.
4. Provide engineering input in the design, fabrication, development, installation, validation, and qualification of equipment / processes which may include feasibility studies and/or proper documentation for justification of project and training to ensure proper operation of the equipment.
5. Provide assistance for planning and implementation of projects to develop, install, and qualify new processes for manufacturing new products or improving existing processes.
6. Research and implement cost reduction projects.
7. May assist in maintaining plant-wide calibration system and drawing control/document control system.
8. Gather, track, and analyze production data for meetings, business plan, etc. (yields/output/efficiencies).
9. Plan work schedules, expenditures, attend meetings, and prepare monthly reports as required.
10. Perform other duties as assigned.
Qualifications/ Background ExperiencesRequires a four-year college degree in an engineering, scientific, or technical discipline and a minimum of three years of experience in an engineering, scientific or technical environment or a Master's degree in an engineering, scientific, or technical discipline and a minimum of two years of experience in an engineering, scientific or technical environment. Basic computer software skills, i.e. Microsoft Office. Experience in medical device industry preferred.
Preferred qualifications:
- Bachelor's degree in mechanical engineering, plastics engineering, or manufacturing engineering.
- Minimum three years of expereince with injection molding thermoplastic components, preferably in medical device or regulated manufacturing environments.
- Experience with mold qualifications, process validations (IQ/OQ/PQ), DOE, and statistical analysis.
- Knowledge of scientific molding principles and materials used in medical devices.
- Scientific Molding certifications, i.e. Master Molder (RJG) or Molder's Series (AIM).
- Six Sigma Green Belt or equivalent.
- Familiarity with ISO 13485, FDQ Quality System Regulations, and risk management practices.
The annualized base salary range for this role is $76,323.00 to $95,874.00. Final compensation packages will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand.
