Summary/Objective:This position supports the 2nd shift production team, whose scheduled hours are 3:45 p.m. to 2:15 a.m., Monday through Thursday.
The Production Engineer designs, develops, and implements manufacturing processes and procedures that meet product specifications and requirements. The position ensures production processes are efficient, cost-effective, safe, and compliant with applicable quality standards and regulations.
As a key production support resource, the engineer monitors process and equipment performance, identifies and resolves problems, implements improvements, and coordinates with engineers, technicians, operators, managers, customers, suppliers, and other stakeholders to achieve production goals 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 (GMP).
- Ensure compliance with ISO 13485, FDA 21 CFR Part 820, OSHA requirements, internal policies, and other applicable quality and safety regulations.
- Make timely decisions using analysis, experience, judgment, and available data.
- Monitor and analyze key performance indicators, including yield, scrap, downtime, and cycle time, and implement corrective actions as needed.
- Develop process improvements that effectively utilize equipment and materials to maximize production.
- Implement continuous improvement initiatives using Lean manufacturing principles and tools.
- Troubleshoot and resolve technical issues involving machinery, equipment, or software using root cause analysis and corrective action techniques.
- Coordinate multiple project activities concurrently to meet timelines, use resources effectively, and adapt to changing priorities in a start-up environment.
- Collaborate with Engineering, Quality, Maintenance, Supply Chain, technicians, operators, managers, and other cross-functional partners to support production goals.
- Communicate with customers, suppliers, and other stakeholders as needed to support customer satisfaction and product quality.
- Establish and maintain professional working relationships with all levels of staff, clients, suppliers, and the public.
- Demonstrate accuracy and thoroughness, monitor work to ensure quality, and consistently meet deadlines.
- Practice and advocate safe work practices at all times.
- Perform other duties as assigned.
Required Education and ExperienceKnowledge, Skills & Abilities:
- Ability to apply Quality System Regulation and Good Manufacturing Practice principles.
- Ability to use basic hand tools, including drills, soldering irons, micrometers, and calipers.
- Ability to operate electrical and mechanical equipment and interpret test or process results.
- Ability to read and interpret mechanical drawings and electrical schematics.
- Proficiency with Microsoft Office and online applications.
- Ability to work effectively with minimal supervision and within a cross-functional team environment.
- Excellent interpersonal, verbal, and written communication skills, with meticulous attention to detail and deadlines.
Minimum Certifications/Educational Level:
- Bachelor's degree in Mechanical, Manufacturing, Industrial, or Biomedical Engineering, or an equivalent combination of education and applicable work experience.
Minimum Experience:
- 2-5 years of relevant experience in a medical device manufacturing environment.
- Experience in the medical device or consumer electronics industry.
- Experience working in FDA, GMP, and ISO-regulated environments.
Work Schedule- Full-time, onsite position with regular presence on the manufacturing floor.
- Special projects may require extended work hours, schedule adjustments, or additional coverage based on business and production needs.
Work Environment and Personal Protective Equipment- This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, and scanners. Personal Protective Equipment may be required when working in designated production, laboratory, or controlled areas.
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$85,000 - $115,000
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
