Senior Process Engineer, Medical Devices | On-Site Bedford

Anika Therapeutics; Bedford (MA); Hybrid; USD 122,000 - 152,000; Full time

Benefits offered by this job

Discretionary bonus

Health benefits

401(k) with company match

Employee stock purchase plan

Job summary

Anika Therapeutics is seeking a Senior Process Engineer to lead process development and equipment implementation in our Bedford, MA facility. This on‑site role offers hybrid flexibility for project needs and focuses on safe, compliant manufacturing of medical devices and drug products.

You will drive process improvements, validate equipment, and collaborate across Manufacturing, Facilities, Validation, R&D, QA, Regulatory, IT, and external partners to bring new products into production.

Qualifications

• Experience leading process development and improvement in regulated manufacturing.
• Proven ability to translate engineering concepts into scalable production solutions.
• Strong knowledge of cGMP, validation, and regulatory expectations.
• Experience with equipment commissioning, qualification, and PV activities.
• Ability to manage multiple projects and collaborate with cross‑functional teams.

Responsibilities

• Lead process development, equipment selection, purchase, and implementation in compliance with cGMP.
• Identify cost reductions, improve efficiency, standardize processes, and automate where feasible.
• Develop and manage engineering projects aligned with priorities and goals.
• Collaborate with suppliers to evaluate materials meeting technical requirements.
• Apply Lean, Six Sigma, and statistical methods to optimize manufacturing.
• Support FAT/SAT, IOQ, PQ, PV, and related documentation throughout validation.

Skills

Process optimization

Cross-functional collaboration

Project leadership

cGMP knowledge

Lean Six Sigma

Education

Bachelor’s degree in Chemical or Mechanical Engineering

Tools

Microsoft Project

Job description

Anika Therapeutics is seeking a Senior Process Engineer to lead process development and equipment implementation in our Bedford, MA facility. This on‑site role offers hybrid flexibility for project needs and focuses on safe, compliant manufacturing of medical devices and drug products.

You will drive process improvements, validate equipment, and collaborate across Manufacturing, Facilities, Validation, R&D, QA, Regulatory, IT, and external partners to bring new products into production.