Sr. Mechanical Engineer

Actalent; Pleasanton (CA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Short-Term Disability

Long-Term Disability

Health Savings Account

Transportation benefits

Employee Assistance Program

Paid time off

Vacation leave

Sick leave

Job summary

Actalent seeks a senior technical leader to guide sustaining and improving Class II/III cardiovascular devices, including VADs, blood pumps, and oxygenators. You will direct investigations, testing, risk mitigation, manufacturing and supplier support, and lifecycle improvements while ensuring regulatory and quality compliance.

The role requires a bachelor's in a relevant engineering field and 15 years of medical-device experience; a master's and cardiovascular device background are preferred.

Qualifications

• A bachelor's degree in mechanical, biomedical, manufacturing, or a related engineering discipline and 15 years of progressively responsible medical-device engineering experience are required.
• A relevant master's degree and cardiovascular device experience are preferred.

Responsibilities

• Provide technical leadership for sustaining and improving Class II and Class III cardiovascular medical devices (including VADs, blood pumps, oxygenators).
• Lead investigations, testing, risk mitigation, manufacturing and supplier support, and cross-functional product lifecycle improvements.
• Ensure regulatory and quality compliance throughout development and manufacturing processes.

Skills

Mechanical Engineering

Medical Device Design

Sustaining Engineering

Root Cause Analysis

FDA Design Controls

21 CFR Part 820

GD&T

Tolerance Analysis

Risk Management

FMEA

Verification And Validation

Reliability Engineering

Failure Analysis

Manufacturing Processes

Supplier Qualification

Cross-Functional Technical Leadership

Education

Bachelor's degree in mechanical, biomedical, manufacturing, or related engineering

Master's degree preferred

Job description

Provide technical leadership for sustaining and improving Class II and Class III cardiovascular medical devices, including VADs, blood pumps, and oxygenators. Lead investigations, testing, risk mitigation, manufacturing and supplier support, and cross-functional product lifecycle improvements while ensuring regulatory and quality compliance.

Requirements: A bachelor's degree in mechanical, biomedical, manufacturing, or a related engineering discipline and 15 years of progressively responsible medical-device engineering experience are required. Candidates should bring expertise in mechanical design, GD&T, tolerance analysis, manufacturing, risk management, FDA design controls, and complex investigations; a relevant master's degree and cardiovascular device experience are preferred.

Key Skills: Mechanical Engineering, Medical Device Design, Sustaining Engineering, Root Cause Analysis, FDA Design Controls, 21 CFR Part 820, GD&T, Tolerance Analysis, Risk Management, FMEA, Verification And Validation, Reliability Engineering, Failure Analysis, Manufacturing Processes, Supplier Qualification, Cross-Functional Technical Leadership

Benefits: Medical Insurance, Dental Insurance, Vision Insurance, Critical Illness Insurance, Accident Insurance, Hospital Insurance, 401(k) Retirement Plan, Life Insurance, Short-Term Disability, Long-Term Disability, Health Savings Account, Transportation Benefits, Employee Assistance Program, Paid Time Off, Vacation Leave, Sick Leave