Sr. Mechanical Engineer

ACON Laboratories; San Diego (CA); On-site; USD 100,000 - 130,000; Full time

Job summary

ACON Laboratories is seeking a Sr. Mechanical Engineer to join its R&D team to develop electromechanical devices, plastic housings, and automated production equipment for high-volume diagnostic manufacturing.

The role requires a bachelor’s in mechanical engineering, 8+ years of design experience with electromechanical products and familiarity with FDA design controls and ISO 13485. Master’s degree is a plus as the company emphasizes quality and scalable production.

Qualifications

• Bachelor's degree in Mechanical Engineering required; master's preferred.
• 8+ years mechanical design experience in electromechanical products or automation.
• FDA/ISO experience and design controls knowledge preferred.

Responsibilities

• Work within an FDA/ISO regulated design control system.
• Design, build, test electromechanical assemblies and plastic housings.
• Prepare technical documentation and manage version control from prototyping to production.
• Support product transfer to production with internal resources.
• Provide design reviews and input to product designs.
• Develop production equipment, fixtures, jigs, and assembly systems for high-volume manufacturing.

Skills

Communication

Systems design

Documentation

Education

Bachelor’s degree in Mechanical Engineering

Master’s degree preferred

Tools

SolidWorks

GD&T

Injection molding

Sheet metal

Job description

At ACON labs, we are making a difference in medical care by offering medical devices for diagnosing a variety of conditions. In addition, we are able to streamline and reduce costs for the physician and/or patient directly. Come join us in developing the latest technologies that enhance human life and be a part of our growing, dynamic company.

We are seeking a Sr. Mechanical Engineer to join our R&D team to develop electromechanical devices, plastic housing designs, and automated production equipment for instrumentation products and low-cost, high-volume medical diagnostic manufacturing.

Essential Duties and Responsibilities

• Work within a regulated (FDA and ISO) product development system;
• Apply FDA design control requirements;
• Design, build, and test electromechanical assemblies, plastic housings, and related mechanical parts for medical instruments;
• Prepare technical documentation, manage version controls from prototyping through production;
• Support product transfer to production with ACON Bio and other internal resources.
• Provide design reviews and technical input to ACON Bio product designs;
• Support design, specification, and improvement of production equipment, fixtures, jigs, and assembly systems for high-volume diagnostic manufacturing (LFA, cartridge, or analyzer lines);
• Create SolidWorks (or equivalent) models, drawings, and assemblies with DFM, DFA, and reliability;
• Apply injection-molding and sheet-metal process knowledge to component and equipment designs; and
• Assist in special projects as defined by the management.

Required Education and Experience:

• Bachelor’s degree in Mechanical Engineering or a related field required; Master’s preferred.
• Eight or more years of mechanical design experience, including five years on electromechanical products, automation, or high-volume plastics. Medical device, IVD, or FDA/ISO experience strongly preferred.
• Experience releasing designs through prototype, pilot, and volume production (design reviews, ECO/ECR, configuration control).
• Experience with production fixtures, jigs, or automated assembly equipment is a plus.
• Working knowledge of FDA design controls and ISO 13485 / 21 CFR 820.
• System-level design of electromechanical assemblies, including requirements, error budgets, and reliability.
• Understand product configuration management, part numbering systems, and ability to put together and document a reasonable product structure;
• DFM/DFA for high-volume injection-molded plastics and sheet metal.
• SolidWorks (or equivalent) for parts, assemblies, and drawings; ASME Y14.5 GD&T
• Clear written and verbal communication; works well with architecture, PM, manufacturing, and quality.

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At ACON it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The annual salary range for this position is $100,000 - $130,000.

ACON offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and ACON may amend, terminate, or enhance the benefits provided, as it deems appropriate.