Summary/Objective:The Production Engineer will design, develop and implement manufacturing processes and procedures that meet the specifications and requirements of the products. Ensuring that the production processes are efficient, cost-effective, safe and compliant with quality standards and regulations is imperative. As a key support for production, the engineer will monitor and analyze the performance of the production processes and equipment, identify and solve problems, implement improvements and innovations, and coordinate with other engineers, technicians, operators and managers to achieve the production goals. The engineer will also communicate with customers, suppliers and other stakeholders to ensure customer satisfaction and product quality.
Essential Duties and Responsibilities[Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Qualified candidates who need a reasonable accommodation with the application process and/or to perform the essential functions of the position should notify the company's HR contact]
- Support company goals and objectives, policies and procedures, and Good Manufacturing Practices.
- Ensure compliance with quality standards such as ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes and FDA 21 CFR Part 820 Quality System Regulation as well as safety regulations such as OSHA.
- Ensure that all regulatory and internal policies are followed.
- Makes decisions in a timely manner, based upon a mixture of analysis, wisdom, experience and judgment.
- Monitor and analyze key performance indicators such as yield, scrap, downtime, cycle time, etc. and take corrective actions as needed.
- Develop process improvements to effectively utilize equipment and materials to maximize production.
- Implement continuous improvement initiatives using lean manufacturing principles and tools.
- Troubleshoot and resolve technical issues with machinery, equipment, or software using root cause analysis and corrective action techniques.
- Coordinate multiple project activities concurrently to achieve timeline requirements; use resources effectively and efficiently while adjusting to changing priorities in a start-up environment.
- Collaborate with cross-functional teams such as engineering, quality, maintenance, and supply chain to support production goals.
- Ability to establish, build and maintain professional working relationships with all levels of staff, clients, suppliers and the public.
- Ability to work with minimal supervision.
- Excellent interpersonal, verbal and written communication skills. Meticulous attention to detail and meeting deadlines.
- Demonstrates accuracy, thoroughness and monitors own work to ensure quality.
- Practice and advocate good safety skills at all times.
- Special projects will require extended work hours and some travel may be required.
- Other duties as assigned.
Required Education and ExperienceKnowledge, Skills & Abilities:
- Ability to apply principles outlined in Quality System Regulations (QSRs/GMPs).
- Ability to use basic hand tools such as drills, soldering irons, micrometers, calipers, etc.
- Ability to operate electrical and mechanical equipment and interpret results
- Must be able to read and interpret mechanical drawings and electrical schematics.
- Proficient with Microsoft Office and on-line applications.
- Ability to work well with others in a cross-functional team environment.
Minimum Certifications/Educational Level:
- Bachelor's Degree in Mechanical, Manufacturing, Industrial, Biomedical Engineering or combination of education and applicable work experience.
Minimum Experience:
- 2-5 years of experience in a medical device environment.
- Experience in Medical Device, or Consumer Electronics.
- Experience in FDA/GMP/ISO environment.
Work Environment and Personal Protective Equipment- This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopier, and scanners.
Physical Demands- While performing the duties of this job, the incumbent is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with co-workers.
- This position requires travel up to 5% depending upon business needs.
Salary Range$80,000 - $110,000
Benefits- Comprehensive medical and dental coverage
- FSA and HSA Plan Options, including an annual company contribution to the HSA
- 401(k) program with employer match
- Generous vacation accrual and paid holiday schedule
