Senior Product Engineer - $103k - $127k + 7% Annual bonus + Equity ($5k) & Unlimited PTO
US citizens and Green card holders only
No C2C
Position Objective
Provide expert engineering support for a range of products through all phases of product development and manufacturing; bring new products on-line ensuring desired functionality, efficient manufacture, and regulatory compliance; refine existing product processing in order to increase efficiency while maintaining required quality requirements; and troubleshoot and resolve production problems for assigned products.
Responsibilities
- Collaborate with Production, Product Development, and other teams to understand and improve product functionality, performance, and safety.
- Manage new product introduction schedules, activities, and cross-product issues throughout the product lifecycle.
- Identify, evaluate, and implement complex manufacturing processes.
- Coordinate with Production, Quality Control, Process Engineering, and Quality Assurance to define, integrate, and validate manufacturing and inspection processes.
- Design or review engineering drawings, specifications, procedures, tooling, fixturing, or gaging for product processing and inspection.
- Determine disposition of discrepant materials or components.
- Ensure availability of acceptable raw materials and components, including identifying new vendors and communicating engineering, quality, delivery, and regulatory requirements.
- Analyze manufacturing issues, propose solutions, and coordinate implementation of optimal solutions.
- Develop, review, and update risk assessments for assigned products.
- Implement production changes to improve reliability, reduce cycle times, and enhance yields.
- Collaborate with manufacturing subcontractors to define processes and optimize results.
- Provide expert technical input on product status, including yield, manufacturing, and quality issues, to management.
- Maintain and share knowledge of relevant manufacturing technologies with engineering and production teams.
Additional Responsibilities
Stay updated on manufacturing systems, processes, drawing standards, in-house procedures, GMP, ISO 9000 series, and other regulatory requirements.Provide product cost estimates and implementation schedules.Design and optimize substrate designs for complex carbon-coated components.Travel to vendors, trade shows, or company facilities (possibly overseas) as needed.Perform additional duties as assigned.Build strong relationships with co-workers, demonstrate negotiation and communication skills, and respond appropriately to feedback.Manage time effectively, prioritize tasks, and make sound business decisions.Qualifications
Bachelor’s degree (Engineering strongly preferred).5–8 years of engineering experience, preferably with Class III medical devices.Proficient in A.N.S.I. drawing standards, CAD, manufacturing processes, process control, engineering economics, and project scheduling.Strong understanding of risk assessment and FMEA.Proven ability to bring complex designs into production.Experience in label and IFU design, including coordinating translations.Green Belt in 5S / Lean Manufacturing preferred.Self-starter with strong leadership, communication, and problem-solving skills.Proficient in MS Office (2000 or later), internet, and email.Excellent interpersonal and communication skills.