Full-Time

Senior Product Manufacturing Engineer

Confirmed live in the last 24 hours

 identifeye HEALTH

identifeye HEALTH

11-50 employees

Portable device for non-invasive health detection

Data & Analytics
Hardware

Compensation Overview

$115,000 - $145,000Annually

+ Annual Bonuses + Equity + Program-specific Awards

Senior

Branford, CT, USA

Required Skills
Communications
Requirements
  • Bachelor's Degree in Mechanical, Electrical, Manufacturing or a related engineering discipline
  • 5+ years of applicable engineering experience, with at least 3 years within medical devices
  • Familiarity with quality and regulatory requirements including FDA's Quality System Regulation, ISO 13485, etc.
  • 3+ years of experience in process validation (IQ/OQ/PQ) and working knowledge of DFMEA and PFMEA
  • Knowledge of Design for Excellence principles (e.g. DFM, DFA, DFT, DFS)
  • Prior experience with contract manufacturers and suppliers, including ECOs and SCARs
  • Strong written and verbal communication skills
  • Strong presentation and negotiation skills, with ability to influence internal and external customers on technical issues
  • Strong organizational skills
  • Experience with Google Workplace and Microsoft Suite
Responsibilities
  • Lead process development support with our CM partners and associated suppliers on establishing the appropriate capital assembly tooling strategies
  • Support the coordination and review with our CM partners on cost of goods estimations, capacity planning models, manufacturing builds, and process validation efforts
  • Support cost down initiatives with the CM by actively working with the CM partners and their suppliers to improve efficiencies and aid in problem resolution within the manufacturing work stream
  • Collaborate with R&D on design change management impacts to manufacturing
  • Cross functional team member supporting CM and tier 2 supplier on DFM, DFA, and DFT efforts
  • A technical contributor on DFMEA, and technical lead on PFMEA and control plan efforts
  • Technical oversight with the CM ensuring that bills of materials, assembly drawings, and assembly process instructions are clearly defined
  • A cross functional lead in collaboration with all R&D, QA/RA, and the CM on labeling, graphics and general operational initiatives
  • Advise management on programmatic developments which impact schedule and costs

Identifeye HEALTH

Company Stage

Series B

Total Funding

$80M

Headquarters

Guilford, Connecticut

Founded

2018

Growth & Insights
Headcount

6 month growth

-4%

1 year growth

0%

2 year growth

2%