Senior Device Engineer - Robustness & Medical Devices

BioSpace; Cambridge (MA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Retirement And Savings Plan

Group Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Flexible Spending Accounts

Annual Bonus Program

Stock-based Long-term Incentives

Paid Time Off

Job summary

BioSpace is seeking a design-focused engineer to execute Design for Robustness methodologies across mechanical design projects for drug delivery devices. You will provide technical recommendations to reduce variation and work with manufacturing and quality teams to ensure system robustness.

The role emphasizes cross-functional collaboration and adherence to GMP and ISO 13485 standards, with opportunities to influence device reliability from concept through production.

Qualifications

• Engineering degree required with years of experience depending on education level
• Prefer 5+ years of mechanical engineering experience
• Prefer 3+ years in Class II/III medical device development

Responsibilities

• Execute Design for Robustness methodologies across mechanical design projects.
• Provide technical recommendations to reduce variation.
• Collaborate with manufacturing and quality teams to ensure system robustness.

Skills

Kinematic Design

Tolerance Design

Structural Strength Design

Material Design

Design For Assembly

Design For Manufacturing

Root Cause Analysis

Medical Device Development

Injection Molding

GMP Documentation

ISO 13485

ISO 11608

ISO 14971

Risk Management

Systems-level Thinking

Cross-functional Collaboration

Education

Engineering degree

Job description

BioSpace is seeking a design-focused engineer to execute Design for Robustness methodologies across mechanical design projects for drug delivery devices. You will provide technical recommendations to reduce variation and work with manufacturing and quality teams to ensure system robustness.

The role emphasizes cross-functional collaboration and adherence to GMP and ISO 13485 standards, with opportunities to influence device reliability from concept through production.