Manufacturing Engineer at Selux Diagnostics

Boston, Massachusetts, United States

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$96,000 – $125,000Compensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, DiagnosticsIndustries

Requirements

Bachelor’s degree in chemical engineering or other technical discipline
5+ years’ experience
Experience working with and managing contract manufacturing partners
Knowledge of Good Manufacturing Processes (GMP)
Familiarity with the NPI process and design for manufacturing principles
Self-motivated, excellent oral and written communicator, goal oriented, and a team player
Ability to travel >50%
Remaining current on cGMP and FDA guidelines as related to medical devices

Responsibilities

Collaborate directly with contract manufacturing partners as part of scale-up efforts on Selux’s AST Panel manufacturing program, including system support during validation, maintenance, and optimization activities
Ability to travel and visit Contract Manufacturing partners as necessary. Significant onsite support is anticipated during initial system installation and first year of operation runs
Collaborate cross-functionally within the Selux organization alongside Engineering, Chemistry, and Microbiology teams during product development, Quality for product and process documentation, V&V and Regulatory teams during product validation, and Operations for continued product support and improvement
Manage PM, repair, and inventory of spare parts for the panel manufacturing line
Work with Planning lead and Supply Chain Management to understand forecasts and develop production schedules with Contract Manufacturers
Provide support as necessary to develop and perform validation and verification for activities
Develop and report on KPIs of the panel manufacturing program
Position allows for part-time work from home when scheduling permits
Other duties as assigned

Skills

GMP

cGMP

NPI

Design for Manufacturing

SOPs

Validation

Commissioning

Contract Manufacturing

Automated Manufacturing

Medical Devices

FDA Guidelines

Selux Diagnostics

Provides rapid antibiotic susceptibility testing

About Selux Diagnostics

Selux Diagnostics focuses on antibiotic susceptibility testing (AST) to address the growing issue of antimicrobial resistance (AMR). The company provides healthcare providers, particularly hospitals, with rapid and comprehensive testing services that evaluate the effectiveness of various antibiotics against bacteria. This technology allows for simultaneous testing against all relevant antibiotics, which is a significant advancement in a field that has seen little innovation in recent years. By delivering faster diagnostic results, Selux helps ensure that patients receive the correct antibiotics, reducing the risk of ineffective prescriptions. The goal of Selux Diagnostics is to preserve the effectiveness of antibiotics for future generations and combat the global health crisis posed by AMR.

Boston, MassachusettsHeadquarters

2014Year Founded

$175MTotal Funding

LATE_VCCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees

Benefits

Health Insurance

401(k) Company Match

Unlimited Paid Time Off

Parental Leave

Risks

Increased competition in the rapid AST market threatens Selux's market share.

Reliance on continuous funding poses financial risks if future funding is challenging.

Potential FDA approval delays could hinder product expansion and competitiveness.

Differentiation

Selux offers the only single-platform technology for rapid AST from blood cultures.

Their Next Generation Phenotyping platform provides personalized antimicrobial therapies quickly.

Selux's AST technology tests against all commercially relevant antibiotics simultaneously.

Upsides

Recent $48 million funding round supports aggressive expansion and product development.

FDA clearance for Gram-Negative Panel enhances Selux's comprehensive AST platform.

Growing demand for rapid diagnostics boosts Selux's market potential.

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