Device Engineering Sr. Engineer

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

The role focuses on executing Design for Robustness methodologies across mechanical design projects to optimize drug delivery devices. Key duties include providing technical recommendations to reduce variation and collaborating with manufacturing and quality teams to ensure system robustness.

Requirements

Candidates must have an engineering degree with varying years of experience depending on the level of education (up to 10 years for high school). Preferred qualifications include 5+ years of mechanical engineering experience and 3+ years in Class II/III medical device development.

Key Skills

• Kinematic Design
• Tolerance Design
• Structural Strength Design
• Material Design
• Design For Assembly (DFA)
• Design For Manufacturing (DFM)
• Root Cause Analysis
• Medical Device Development
• Injection Molding
• GMP Documentation
• ISO 13485
• ISO 11608
• ISO 14971
• Risk Management
• Systems-level Thinking
• Cross-functional Collaboration

Benefits

• 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