Hire Power Associates

A small, stable Medical Device firm in metrowest- Boston is making a critical hire.

They have developed a breakthrough medication dosing/delivery system for pharmaceutical manufacturers and laboratories and are being endorsed as the delivery system of choice by regulatory authorities.

This is a tight knit group devoted to technical excellence & maintaining a sane work/life balance.

This will be the Senior Mechanical Engineering resource…. a hands-on Product Development Engineer & Project Lead (BS/MSME) who will drive the creation of an automated instrumentation platform comprising motion control, opto-electro-mech HW/SW/Firmware, sensors & electronics – Motors, actuators, drivetrains/bearings & machine vision elements.

They need a mature communicator & technical leader who has delivered products from concept stage to commercial release. To oversee in/external resources and serve as a mentor/leader.

Advanced SolidWorks skills are required, as is knowledge of molding/forming/machining fabrication processes of plastics & metals.

Primary responsibilities include:
· Advanced conceptual and detail designs for complex systems
· Tend to big picture architecture design AND details of troubleshooting E/M subsystems
· Prototype development/design/testing/analysis – simulation/performance analyses/root cause diagnostics
· Produce/conduct feasibility studies – including generation of well documented test plans.
· Develop/define best design/test practices
· Manage new product development BOMs and provide Eng'g. interface for Mfg. operations.
· Coordinate design, construction & implementation of test fixtures for production
· Additive manufacturing processes

Only Permanent Residents or US Citizens will be considered for this position

Please sends your CV and a short note indicating why you believe you're the best candidate for this position to:

Neil Rauch, President
ire Power Associates
410-318-6737 / 978-808-9898 ©
[email protected]

Matching exceptional candidates
with discerning clients for 30+ years.

Senior Mechanical Engineer/Product Development
Multi-disciplinary product development team to create, design, implement, test and deliver innovative instrumentation technology and automation solutions for characterizing aerosol and spray drug products.

Our technology platform combines motion control, opto-mechanical hardware, sensors, electronic PCBs, software and firmware into standard setting instruments used by regulatory authorities, pharmaceutical companies, contract laboratories and other organizations around the world.

Must have a strong work ethic, engineering acumen, proven builder of complex low volume products

Can think from big picture design architecture down to details of troubleshooting E/M subsystems and anything in between to get the job done.

• Team player/small-team environment - product development, product mgt, marketing, mfg & tech support to define requirements/specs, manage project scopes, deliver relevant work products, enhancements, and utilities for customer success.
• Produce advanced conceptual and detail designs for complex system mechanics/hardware and prototype those designs as needed.
• Be an active organizer, participant, and leader of design reviews.
• Produce/conduct feasibility studies – generate well-documented test plans.
• Manage new product development BOMs. Provide Engineering interface for Manufacturing operations.
• Develop/define best design practices for development/test: use simulation modeling, functional testing etc.
• Help manage projects - provide technical oversight for in/external resources.
• Coordinate design/construction/implementation of test fixtures for production
• Act as vendor liaison to support technology suppliers as required.
• Lead/manage/Mentor engineers.

Competencies:
• Opto-electro-mech product design - motors, actuators, drivetrains/bearings, machine vision, motion control.
• SolidWorks - Certified Expert - highly desirable.
• Expertise with additive manufacturing technologies and factoring them into production components.
• Expertise in processes for metals and plastics: CNC machining/turning, sheet metal, molding, thermoforming, plastic and metal fabrication methods.
• Deliver cost-effective, cross-discipline designs - motion, vision, mechanical, electronic, controls, and fluid flow elements with functional, thermal, static and dynamic performance analyses.
• Outstanding communications skills – diagram on white boards; write detailed specifications documents.
• Proven expertise with first principles analyses and root cause diagnostics at the systems level.
• Track record of delivering on product development projects from concept stage to commercial release.
• Has both theoretical & practical experience – hands-on in a lab environment; exp. using basic equipment.
• Energetic problem-solver/results-driven, with excellent time-mgt, planning/org/written/verbal skills.

Qualifications:
• BS/MSME - 5+ years system development experience - advanced knowledge of mechanical design.
• Significant prototype development/testing - hardware design and analysis.
• Devise solutions for unique and complex problems.
• Can reprioritize and change direction depending on emergent requests.
• Prior mgt/oversight/delivery of multiple projects on budget and schedule.
• Advanced comm skills - present concepts/ideas in a clear/coherent manner
• Experience in an internationally recognized quality mgt system (ISO9001).
• Minimal, if any travel. (Should have passport/driver’s license)
• Exemplifies discretion, integrity and a strong sense of work ownership.

Sr. Quality Engineer - Support Product Development team. Validate/verify Design Control for drug-delivery devices: Design Verif./Valid., and Design Transfer efforts; ensure requirements are met.

• Write/coordinate development & implementation of new/updated Quality System procedures for ISO/QSR: verif./valid. protocols, manufacturing procedures, product & material specs, design/development documentation, SOPs, and development & task force projects
• Support 510(K) filing for new products
• Support launch of approved devices: Technology transfer from development to commercialization from a Quality/Manufacturing perspective
• Facilitate ex*****on of Risk Mgt and Usability Engineering process activities
• Develop statistically-based sampling plans for incoming, in-process and final testing and inspections, and process validations
• Lead new supplier qualification & assessment of finished goods, components, raw materials & services
• Work with in/external inspection resources to fulfill incoming inspection requirements for device components
• Work with project teams to develop statistically sound tests (DOE) to support results
• Develop, review & approve validations and completion reports for new and existing products, processes and equipment
• Apply statistical analysis to support data-driven decision making
• Ensure all projects comply with GMP, QSR, ISO or other requirements
• Participate in FDA inspections, ISO Certification; oversee audits and customer audits
• Identify/implement continuous improvements in product quality/ quality system
• Interact with & coordinate activities with other departments, external vendors and customers
• Lead root cause analyses of failure investigations – Lead/support Corrective & Preventative Action(s) implementation and/or review
• Reports to QA Manager.

Min Reqs:
• BS/MS ME/IE/Mfg Eng -4-6 yrs in a QE/QA role (medical device/pharma mfg)

Ideal
• Prior product development projects in the medical device industry
• 510(k) submissions and/or FDA inspections
• Expertise in risk management per ISO 14971
• MS Office Suite, statistical sampling & analysis tools (inc. Minitab)
• Six Sigma Green/Black Belt Certification
• Excellent organizational, verbal and written communication skills