Sr Process Engineer

Medtronic•Humacao, PR

3d•Onsite

About The Position

The Senior Process Engineer with extensive experience leading process development, optimization, and validation in regulated manufacturing environments. Proven ability to drive continuous improvement initiatives, ensure compliance with quality and regulatory standards, and collaborate cross‑functionally with R&D, Quality, Operations, and Supply Chain. Strong background in process characterization, root cause analysis, and implementation of scalable, cost‑effective manufacturing solutions that improve yield, reliability, and operational efficiency.

Requirements

Requires a Baccalaureate degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.
Engineering degree required
Lean Manufacturing & Six Sigma (Green Belt or Black Belt certification)
Advanced statistical analysis (DOE, SPC, MSA, process capability studies)
Automation and digital manufacturing experience
Equipment qualification & validation leadership (IQ/OQ/PQ)
Risk management tools (FMEA, Fault Tree Analysis)
Regulatory knowledge (FDA QSR, ISO 13485, GMP)
Design for Manufacturability (DFM/DFA) collaboration with R&D
Change management & ECO execution
Data analytics tools (Minitab, JMP, Power BI, Python for data analysis)
Supplier process development & oversight
Technology transfer / scale‑up experience
Cost reduction and value engineering
Project management (Agile, PMP fundamentals)
Mentoring or technical coaching of junior engineers
Strong technical writing (protocols, reports, submissions support)
Experience in Nonconformance investigations (NCMR, CAPA investigation)
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Responsibilities

Provides technical and sustaining engineering support in a manufacturing area.
Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products.
Integrates equipment and material capabilities to meet process module target specifications and technology target specifications.
Reviews product development requirements for compatibility with processing methods to determine costs and schedules.
Interacts with product design and development personnel to ensure that processes and designs are compatible.
May develop and conduct statistical analysis or recommend additions to document work.
Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations.
This can include scouting and feasibility work, material selection, process and equipment selection, tooling / fixture and equipment installation and assessment of inputs, outputs and alignment to requirements.
Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems.
Ensures processes and procedures are in compliance with regulations.